General Purpose Instrument Tray
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
1 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
15 firms currently registered for this product code
Tri-state De Mexico, S. De R.l. De C.v.
MEXICALI Baja California, MX
Medmetalex Co., Ltd.
Osaka, JP
Ssc- Surgical Specialties Corporation
Chula Vista, CA, US
Blink Medical Ltd
Solihull, GB
Cardinal Health 200, Llc
El Paso, TX, US
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Sterigenics Us Llc
Grand Prairie, TX, US
Isomedix Operations Inc
El Paso, TX, US
Cygnus Medical Llc
Branford, CT, US
Madison Polymeric Engineering
BRANFORD, CT, US
Cardinal Health 200, Llc
Waukegan, IL, US
Sterigenics U.s., Llc
Charlotte, NC, US
Isomedix Operations Inc
EL PASO, TX, US
Dongguan Hong De Medical Plastic Products Co. Ltd.
Dongguan Guangdong, CN
International Manufacturing Solutions Operaciones
Cd. Juarez Chihuahua, MX
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.