GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)
Convatec · Gastroenterology, Urology
Open FDA's page for this record- Third party flag
- N
- City
- Flintshire
- Advisory committee description
- Gastroenterology, Urology
- Address 1
- First Ave., Deeside Industrial Estate
- Address 2
- Deeside
- Statement or summary
- Summary
- Product code
- EZD
- Zip code
- CH5 2NU
- Applicant
- Convatec
- Decision date
- 2024-01-25
- Decision code
- SESE
- Country code
- GB
- Device name
- GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)
- Advisory committee
- GU
- Contact
- Kim Jones
- K number
- K232665
- Date received
- 2023-08-31
- Review advisory committee
- GU
- Postal code
- CH5 2NU
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Catheter, Straight
- Medical specialty description
- Gastroenterology, Urology
- Regulation number
- 876.5130
- Device class
- 2
- Registration number
- 3023329815, 3006405073, 3030671614, 3005690789, 9617594, 8043792, 3008502431, 3006673317, 3014421917, 2029015, 8040412, 1061124, 9611590, 1055236, 3010580321, 3008729910, 3003974574, 2030598, 2953359, 3006260740, 3007697249, 1921846, 3005515211, 3003903031, 3007738736, 1417592, 3015142802, 3005669815, 3016675012, 3009632672, 2024024, 3006891611, 3007007790, 3008806809, 1000317571, 3014404707, 3016171914, 3033919393, 3005778470, 3011987967 +50 more
- FEI number
- 3023329815, 3006405073, 3030671614, 3005690789, 3008502431, 1000160458, 3014421917, 3002808269, 3010580321, 3008729910, 3003974574, 3001236905, 3006260740, 3007697249, 3003076831, 1000237915, 3002806731, 1921846, 3005515211, 3003903031, 3007738736, 1417592, 3015142802, 3005669815, 3016675012, 3009632672, 2024024, 3006891611, 3007007790, 3008806809, 3002806934, 1000317571, 3014404707, 3005028195, 3016171914, 3033919393, 3005778470, 1000306139, 3011987967, 3003058448 +50 more