Cotton, Roll
Dental · 21 CFR 872.6050
Recent MDR events
7 adverse event reports on file
- HENRY SCHEINFeb 2, 2018MalfunctionA.r. Medicom Inc. (shanghai) Co.,ltd.9611959-2015-00001
- HENRY SCHEINJul 16, 2015InjuryA.r. Medicom Inc. (shanghai) Ltd.2411236-2015-00005
- DOUBLE-STRUNG COTTON BALLSMar 6, 2015MalfunctionDeroyal Industries, Inc.3010452421-2015-00001
- HENRY SCHEIN NON STERILE COTTON ROLLS #2Mar 15, 2010OtherA.r. Medicom, Inc.9680179-2010-00001
- HENRY SCHEIN NON STERILE COTTON ROLLS #2Mar 5, 2010InjuryA.r Medicom Inc.2411236-2010-00001
- KLINGAug 22, 2000InjuryJohnson & Johnson Medical Inc.MW1019761
- MEDIPAK - STOCKINETTE 6" X 72"Aug 18, 2000MalfunctionPrivate Labeled Manufactured For MckessonMW1019709
Event type breakdown
Recalls
2 recall events for this product code
- Carwild CorporationOpen, ClassifiedUnknown
FABCO ORS DENTAL ROLLS, 1-1/2" STERILE, COTTON 3/8" Diameter x 1-1/2"
Sterility with new cotton source not validated
Z-1747-2022 · View FDA record ↗ - American Surgical CompanyTerminatedUnknown
American Surgical Cylindrical Sponges-Strung 1/2" x 1.5"
Product packaging defective compromising sterility
Z-1799-2016 · View FDA record ↗
Registered firms
210 firms currently registered for this product code
Shanghai Alwings Medical Instrument Co.,ltd.
Shanghai, CN
Beijing Zksk Technology Co., Ltd.
beijing, CN
Sion Biotext Mexico, S.a.p.i. De C.v
Jiutepec Morelos, MX
Across Medical Disposables Co., Ltd.
ANQING Anhui, CN
La Smile Supply Inc.
S el Monte, CA, US
Dayon Daily Chemical Co., Ltd
Yangzhou Jiangsu, CN
Nantong Hope Industry&trade Co.,ltd.
Rugao Jiangsu, CN
Anhui Jm Healthcare Products Co.,ltd.
Shouxian Anhui, CN
Hefei Haixi Trading Co., Ltd.
Hefei Anhui, CN
Ningbo Betterlife Limited
NINGBO Zhejiang, CN
Atomo Dental, Inc.
Pleasanton, CA, US
Parkom Llc
Las Vegas, NV, US
Dongyang City Yonoel Outdoor Products Co.,ltd
Dongyang Zhejiang, CN
Changzhou Shengkang Medical Instrument Co.,ltd
Changzhou Jiangsu, CN
Battech
Irvine, CA, US
Jiujiang Huada Medical Dressing Co., Ltd.
JIUJIANG Jiangxi, CN
Suzhou Dynarex Co., Ltd
Suzhou Jiangsu, CN
Guangzhou Kaiheng K&s Co.,ltd.
Guangzhou Guangdong, CN
Bgss Company Asia Limited
Zhabei Shanghai, CN
Guangdong Comfort Medical Products Co., Ltd.
Jiangmen Guangdong, CN
Ready Set Import
Beverly Hills, CA, US
Sterigenics U.s., Llc
Charlotte, NC, US
Miracle Medical Industries
El Obour City Al Qahirah, EG
Xiantao S&j Protective Products Co., Ltd
Xiantao Hubei, CN
Plasdent Shanghai Co., Ltd.
Shanghai, CN
510(k) clearances
14 clearances for this product code
- American Silk Sutures, Inc.Dec 4, 1987
K872810 · STRUNG DENTAL ROLLS
- Medgroup Enterprises, Inc.Apr 30, 1987
K871464 · MEDGROUP ENTERPRISES COTTON GAUZE SPONGES-NON STER
- The Medical Group, Inc.Oct 27, 1986
K863764 · COTTON ROLLS, NON-STERILE
- Intl. Verbandstoff-Fabrik SchaffhauAug 6, 1986
K861338 · DENTAL COTTON ROLLS, STERILE AND NON-STERILE
- Cross Country Paper Products Corp.Jul 10, 1986
K861727 · COTTON FILLED GAUZE SPONGES 2 X 2
- Molnlycke A/S Hospital ProductsMay 23, 1985
K843539 · TELEDYNE DENSCO DRY TIPS SALIVA ABSORB-
- Intl. Verbandstoff-Fabrik SchaffhauJul 3, 1984
K841327 · DENTAL COTTON ROLLS
- Henry Schein, Inc.Feb 3, 1984
K834056 · SCHEIN COTTON ROLLS, NON-STERILE