Perineal Irrigation Kit
Gastroenterology, Urology · 21 CFR 876.5980
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
8 firms currently registered for this product code
Sterigenics U.s., Llc
Charlotte, NC, US
Sterigenics Us Llc
Grand Prairie, TX, US
Cardinal Health 200, Llc
Waukegan, IL, US
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Isomedix Operations Inc
EL PASO, TX, US
Cardinal Health 200, Llc
El Paso, TX, US
Isomedix Operations Inc
El Paso, TX, US
Aboel Electronic Technology (shenzhen) Co.,ltd
Shenzhen Guangdong, CN
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.