FDA Registration
Active
🇺🇸 United States
ACTIVE LIFE CONVEX One-Piece Urostomy Pouch Durahesive
Reg #: 3011987967
·
FEI: 3011987967
·
Expires 2025
Products
1
Proprietary Names
15
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, Urine Collecting, Ureterostomy | EXG | Class 1 | Gastroenterology, Urology | No | 2016-12-09 |
Proprietary Names
ACTIVE LIFE CONVEX One-Piece Urostomy Pouch Durahesive
NATURA+ Urostomy Pouch
SUR-FIT NATURA Urostomy Pouch with Accuseal Tap
SUR-FIT Plus Urostomy Pouch Two-Piece
ESTEEM SYNERGY Urostomy Pouch with Accuseal Tap
LITTLE ONES One-Piece Urostomy Pouch
ESTEEM Urostomy Pouch
Little Ones SUR-FIT NATURA Urostomy Pouch Two-Piece Ostomy System
ACTIVE LIFE One-Piece Urostomy Pouch Durahesive
ESTEEM+ Soft CONVEX
SUR-FIT NATURA Urostomy Pouch
ESTEEM+ Urostomy Pouch Durahesive
SUR-FIT System Night Drainage Container
Night Drainage Container Tubing
EsteemBody Urostomy Pouch Ostomy System
Establishment Types
Complaint File Establishment per 21 CFR 820.198