Body Fluids Barrier Kit
General, Plastic Surgery · 21 CFR 878.4040
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
2 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
19 firms currently registered for this product code
Lighthouse For The Blind
Saint Louis, MO, US
Cardinal Health 200, Llc
Waukegan, IL, US
Isomedix Operations Inc
EL PASO, TX, US
Sterigenics Us Llc
Grand Prairie, TX, US
Isomedix Operations Inc
El Paso, TX, US
Katmai Integrated Solutions
Brilliant, OH, US
Honduras Kitting, S.a.
Villanueva Cortes, HN
Deroyal Industries, Inc.
POWELL, TN, US
Sterigenics U.s., Llc
Charlotte, NC, US
Bound Tree Medical, Llc
Grand Prairie, TX, US
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Katmai Health Services Llc
Brilliant, OH, US
Cardinal Health 200, Llc
El Paso, TX, US
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Midwest Sterilization Corp.
JACKSON, MO, US
Medical Action Industries, Inc. 306
ARDEN, NC, US
Lsl Healthcare
Niles, IL, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.