Ostomy Care Kit
Gastroenterology, Urology · 21 CFR 876.5900
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
1 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
1 recall events for this product code
Registered firms
23 firms currently registered for this product code
Hollister Incorporated
LIBERTYVILLE, IL, US
Coloplast A/s
HUMLEBAEK Hovedstaden, DK
Convatec Limited
Deeside Flintshire, GB
Zhende Medical Co., Ltd.
SHAOXING Zhejiang, CN
Teampac Oy
Liljendal Etela-Karjala, FI
Hollister, Inc.
Mount Juliet, TN, US
Able Solutions. Inc
Harrisonburg, VA, US
Convatec Limited, Gdc Building
Deeside Flintshire, GB
Suzhou Kangyouwei Medical Technology Co., Ltd.
Suzhou Jiangsu, CN
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Isomedix Operations Inc
EL PASO, TX, US
Hollister Incorporated
STUARTS DRAFT, VA, US
Coloplast Hungary, Kft
Tatabanya, HU
Shaoxing Haoshide Medical Products Co.,ltd
Shaoxing Zhejiang, CN
Sterigenics U.s., Llc
Charlotte, NC, US
Sterigenics Us Llc
Grand Prairie, TX, US
Cardinal Health 200, Llc
Waukegan, IL, US
Isomedix Operations Inc
El Paso, TX, US
Sterigenics Us Llc
Charlotte, NC, US
Cardinal Health 200, Llc
El Paso, TX, US
Convatec, Inc.
Greensboro, NC, US
Convatec Dominican Republic, Inc.
Haina San Cristobal, DO
Stomagienics, Inc.
Greenville, SC, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.