Surgical Retractor Kit
General, Plastic Surgery · 21 CFR 878.4800
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
10 firms currently registered for this product code
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Teleflex Llc (nadc)
Olive Branch, MS, US
Cardinal Health 200, Llc
El Paso, TX, US
Sterigenics U.s., Llc
Charlotte, NC, US
Opinstruments Gmbh
Rosbach vor der Hoehe Hesse, DE
Sterigenics Us Llc
Grand Prairie, TX, US
Isomedix Operations Inc
El Paso, TX, US
Teleflex Medical Llc
Morrisville, NC, US
Cardinal Health 200, Llc
Waukegan, IL, US
Isomedix Operations Inc
EL PASO, TX, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.