Minor Surgical Procedures Tray
General, Plastic Surgery · 21 CFR 878.4800
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
0 recall events for this product code
No recalls on file for this product code.
Registered firms
30 firms currently registered for this product code
Synchronis Medical Llc
Romulus, MI, US
Synergy Health Sterilisation Uk Ltd
Thorne Doncaster, GB
Arbutus Medical, Inc
Vancouver British Columbia, CA
Isomedix Operations, Inc.
Temecula, CA, US
Invenio Alternate Care Solutions, Llc
Peachtree Corners, GA, US
Deroyal Industries, Inc.
POWELL, TN, US
Blink Medical Ltd
Solihull, GB
Merit Medical Canada Ltd.
Markham Ontario, CA
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Merit Medical Systems, Inc.
South Jordan, UT, US
Hubei Lanbin Medical Group Co., Ltd.
Xiaogan City Hubei, CN
Gri-alleset, Inc.
Flowery Branch, GA, US
Terumo Bct Sterilization Services, Inc.
LAKEWOOD, CO, US
Merit Maquiladora Mexico, S. De R.l. De C.v.
Tijuana Baja California, MX
Robinson Healthcare Limited
Worksop Nottinghamshire, GB
Merit Medical Australia Pty Ltd.
Braiside Victoria, AU
Advanced Product Solutions Inc.
Dothan, AL, US
Merit Medical Nederland Bv
Maastricht Airport Limburg, NL
Ssc- Surgical Specialties Corporation
Chula Vista, CA, US
Midwest Sterilization Corp.
JACKSON, MO, US
Merit Medical Uk Limited
Earley Reading, GB
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Med2b Ltd.
Kitzingen Bavaria, DE
Isomedix Operations, Inc
ONTARIO, CA, US
Sterigenics U.s., Llc
Salt Lake City, UT, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.