Tourniquet Kit
General, Plastic Surgery · 21 CFR 878.5900
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. 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
22 firms currently registered for this product code
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Deroyal Industries, Inc.
POWELL, TN, US
Covidien
TIJUANA, B.C. Mexico, MX
Caremax Co., Ltd.
SUZHOU, JIANGSU PROVINCE, CN
Cardinal Health
Hazelwood, MO, US
Quiroproductos De Cuauhtemoc S. De R.l. De C.v.
Cuauhtemoc Chihuahua, MX
Sterigenics Us Llc
Grand Prairie, TX, US
Hangzhou Rollmed Co.,ltd.
Hangzhou Zhejiang, CN
Cardinal Health 200, Llc
El Paso, TX, US
Fountain Medical Supplies Inc.
Orem, UT, US
Deroyal Intercontinental, S.r.l.
SANTIAGO, DO
Sterigenics U.s., Llc
Charlotte, NC, US
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Cardinal Health 200, Llc
Waukegan, IL, US
Bound Tree Medical, Llc
Grand Prairie, TX, US
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Isomedix Operations Inc
El Paso, TX, US
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Cardinal Health (kenmex Medical Specialties)
TIJUANA Baja California, MX
Sam Medical Products
Tualatin, OR, US
Isomedix Operations Inc
EL PASO, TX, US
Tri-tech Forensics, Inc.
Leland, NC, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.