Oral Surgery Tray
Dental · 21 CFR 872.4565
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf.This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
15 recall events for this product code
- Stradis Medical, LLC dba Stradis HealthcareOpen, ClassifiedDec 14, 2022
ACE Surgical Supply, 17539 CUSTOM KIT STERILE Item No.003-3880, oral surgery tray
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Z-0482-2023 · View FDA record ↗ - Stradis Medical, LLC dba Stradis HealthcareOpen, ClassifiedDec 14, 2022
STRADIS HEALTHCARE, Perio Surgery, Item No. 20177RPSS
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Z-0483-2023 · View FDA record ↗ - Stradis Medical, LLC dba Stradis HealthcareOpen, ClassifiedDec 14, 2022
BASIC IMPLANT PACK, Item No. 40310SBI, oral surgery tray
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Z-0484-2023 · View FDA record ↗ - Stradis Medical, LLC dba Stradis HealthcareOpen, ClassifiedDec 14, 2022
STRADIS HEALTHCARE, Surg Pack, Item No.40450SMS, dental
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Z-0485-2023 · View FDA record ↗ - Stradis Medical, LLC dba Stradis HealthcareOpen, ClassifiedDec 14, 2022
STRADIS HEALTHCARE, Surgical Pk, Item No.40510TWS, oral surgery tray
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Z-0486-2023 · View FDA record ↗ - Stradis Medical, LLC dba Stradis HealthcareOpen, ClassifiedDec 14, 2022
STRADIS HEALTHCARE, Surg, Item No.40551TMS. oral surgery tray
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Z-0487-2023 · View FDA record ↗ - Stradis Medical, LLC dba Stradis HealthcareOpen, ClassifiedDec 14, 2022
STRADIS HEALTHCARE, Basic Implant Pack, Item No.40561BIP, oral surgery tray
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Z-0488-2023 · View FDA record ↗ - Stradis Medical, LLC dba Stradis HealthcareOpen, ClassifiedDec 14, 2022
STRADIS HEALTHCARE, Surgical Pk, Item No.40649ECS, dental
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Z-0489-2023 · View FDA record ↗ - Stradis Medical, LLC dba Stradis HealthcareOpen, ClassifiedDec 14, 2022
STRADIS HEALTHCARE, Surg Pk, Item No.40714IES, oral surgery tray
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Z-0490-2023 · View FDA record ↗ - Stradis Medical, LLC dba Stradis HealthcareOpen, ClassifiedDec 14, 2022
STRADIS HEALTHCARE, pack Item No.40788SMS, oral surgery tray
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Z-0491-2023 · View FDA record ↗
Registered firms
20 firms currently registered for this product code
Gri-alleset, Inc.
Flowery Branch, GA, US
Cordica Medical, Inc. (formally Team Technologies, Inc.)
MORRISTOWN, TN, US
Nova Instruments
Berkshire Wokingham, GB
Cardinal Health 200, Llc
El Paso, TX, US
Sterigenics Us Llc
Grand Prairie, TX, US
Isomedix Operations Inc
El Paso, TX, US
Sterigenics U.s., Llc
Charlotte, NC, US
Osstem Implant Co., Ltd.
Gangseo-gu Seoul, KR
Synergy Health Sterilisation Uk Ltd
Thorne Doncaster, GB
Robinson Healthcare Limited
Worksop Nottinghamshire, GB
Shanghai Lions Industrial Co.,ltd.
SHANGHAI, CN
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Isomedix Operations Inc
EL PASO, TX, US
Hubei Lanbin Medical Group Co., Ltd.
Xiaogan City Hubei, CN
Invenio Alternate Care Solutions, Llc
Peachtree Corners, GA, US
Fabryka Narzedzi Medycznych Chirmed Marcin Dyner Spolka Komandytowa
RUDNIKI K/CZESTOCHOWY Slaskie, PL
Cardinal Health 200, Llc
Waukegan, IL, US
Osstem Implant Co., Ltd.
Haeundae-gu Busan, KR
Shanghai Jolly Industrial Co., Ltd.
Shanghai, CN
Global Resources International Dominicana Grid S.r.l.
San Pedro de Macoris, DO
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.