FDA Registration
Active
🇬🇧 United Kingdom
Eakin Fistual and Wound Pouches
Reg #: 3008806809
·
FEI: 3008806809
·
Expires 2025
Products
1
Proprietary Names
17
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ConvaTec Limited, GDC Building
- Registration Number
- 3008806809
- FEI Number
- 3008806809
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- First Avenue, Deeside Industrial Park
- City
- Deeside Flintshire
- Country
- GB
Owner / Operator
- Firm Name
- ConvaTec
- Operator Number
- 2241599
- Address
- 7815 National Service Road, Suite 600
- City
- Greensboro
- State
- NC
- Postal Code
- 27409
- Country
- US
- Correspondent
- Courtney Smith
US Agent
- Business Name
- ConvaTec
- Contact Name
- Courtney Smith
- Address
- 20 Maguire
- City
- Lexington
- State
- MA
- ZIP
- 02421
- Country
- US
- [email protected]
- Phone
- 239 7762947
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bag, Drainage, With Adhesive, Ostomy | FON | Class 1 | Gastroenterology, Urology | No | 2005-06-06 |
Proprietary Names
Eakin Fistual and Wound Pouches
NATURA Stomahesive CTF Skin Barrier and Urostomy Kit
SUR-FIT NATURA Stomahesive Skin Barrier/Pouch Unit Dose Kits
Trio Diamonds
EsteemBody Drainable Pouch Ostomy System
ESTEEM Synergy Professional Kit - Non-Sterile
ESENTA Strips
Natura + Drainable Pouch
NATURA Drainable and Urostomy Post-Operative Kits
ESTEEM+ One-Piece Pouch Stomahesive Skin Barrier Kit
NATURA Post-Operative Kits
ESTEEM Synergy Professional Kit - Loop Ostomy System - Sterile
GentleTouch System OR Kit - Colostomy
SUR-FIT NATURA Durahesive Skin Barrier/Pouch Unit Dose Kits
GentleTouch System OR Kit - Ileostomy and Urostomy
NATURA Stomahesive Skin Barrier Drainable Pouch Post Operative Kit with Loop Ostomy Rod
Esteem + Drainable Pouch
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility