FDA Registration
Active
🇺🇸 United States
Strattice Reconstructive Tissue Matrix (RTM); Strattice Reconstructive Tissue Matrix Extra Thick
Reg #: 1647098
·
FEI: 1000306051
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- LIFECELL CORP.
- Registration Number
- 1647098
- FEI Number
- 1000306051
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- ONE MILLENNIUM WAY
- City
- BRANCHBURG
- State
- NJ
- ZIP
- 08876
- Country
- US
Regulatory Submissions
- 510(k) Number
- K070560
Owner / Operator
- Firm Name
- AbbVie, Inc.
- Operator Number
- 2011068
- Address
- 2525 DUPONT DRIVE, --
- City
- Irvine
- State
- CA
- Postal Code
- 92612
- Country
- US
- Correspondent
- James P Wabby
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mesh, Surgical | FTM | Class 2 | General, Plastic Surgery | No | 2017-05-30 |
Proprietary Names
Strattice Reconstructive Tissue Matrix (RTM); Strattice Reconstructive Tissue Matrix Extra Thick
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device