Venous Ulcer Kit
General, Plastic Surgery · 21 CFR 878.4014
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
11 firms currently registered for this product code
Sterigenics Us Llc
Grand Prairie, TX, US
Bsn Medical Gmbh
Hamburg, DE
Cardinal Health 200, Llc
El Paso, TX, US
Bsn Medical, Inc.
CHARLOTTE, NC, US
Isomedix Operations Inc
El Paso, TX, US
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Isomedix Operations Inc
EL PASO, TX, US
Lohmann & Rauscher S.r.o.
Nová Paka Jicin, CZ
Cardinal Health 200, Llc
Waukegan, IL, US
Sterigenics U.s., Llc
Charlotte, NC, US
Essity Distribution B.v.
GE Oostrum Fryslan, NL
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.