FDA Registration
Active
🇺🇸 United States
ActiveLife One-Piece Drainable Pouch with Durahesive
Reg #: 3011987967
·
FEI: 3011987967
·
Expires 2025
Products
1
Proprietary Names
21
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ConvaTec, Inc.
- Registration Number
- 3011987967
- FEI Number
- 3011987967
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 7815 National Service Road, Suite 600
- City
- Greensboro
- State
- NC
- ZIP
- 27409
- Country
- US
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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bag, Urinary, Ileostomy | EXH | Class 1 | Gastroenterology, Urology | No | 2007-05-17 |
Proprietary Names
ActiveLife One-Piece Drainable Pouch with Durahesive
ActiveLife One-Piece Drainable Pouch with Durahesive Plus
STOMADRESS Plus
COMBIHESIVE 2S
SUR-FIT NATURA Stomahesive
NATURA+ Drainable Pouch
ESTEEM+ Soft CONVEX
NATURA SUR-FIT High Output Drainable Pouch
LITTLE ONES Two-Pieces Drainable Pouch
ActiveLife One-Piece Drainable Pouch with Stomahesive
SUR-FIT NATURA Drainable Pouch
SUR-FIT Plus Drainable Pouch Two-Pieces
LITTLE ONES Two-Pieces Adhesive Coupling Technology
AutoLock SUR-FIT Drainable Pouch
SUR-FIT NATURA Drainable Pouch with Filter
ESTEEM Synergy+ Drainable Pouch
ESTEEM+ Drainable Pouch
ESTEEM SYNERGY Drainable Pouch
NATURA SUR-FIT Drainable Pouch with InvisiClose Outlet
ActiveLife CONVEX One-Piece Drainable Pouch with Durahesive
LITTLE ONES One-Piece Drainable Pouch
Establishment Types
Complaint File Establishment per 21 CFR 820.198