Strattice Reconstructive Tissue Matrix Laparoscopic
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Strattice Reconstructive Tissue Matrix Laparoscopic FDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial FDA UDI
- Device Name
- Strattice Laparoscopic 10cm x 16cm FDA UDI
- Model / Reference
- 1016005 FDA UDI
- Description
- Strattice Laparoscopic 10cm x 16cm FDA UDI
Identifiers
- Catalog Number
- 1016005 FDA UDI
- Primary DI / UDI-DI
- M32810160050 FDA UDI
- FDA Product Code
- FTM FDA UDI
- GMDN Term
- Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Width — 16 Centimeter FDA UDILength — 10 Centimeter FDA UDI
Category: Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
The Strattice Reconstructive Tissue Matrix Laparoscopic is a bioabsorbable, implantable mesh designed for extra-gynaecological surgical procedures. Made from animal-derived collagen, it provides a scaffold for tissue regeneration and is intended for use in pericardial reinforcement, plastic surgery, and abdominal hernia repair. The device features a unique extracellular matrix structure that promotes tissue integration and healing.
Similar devices
Also classified as Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial.
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- Rotation Medical Reconstituted Collagen Scaffold - Arthroscopic, Medium — Smith & Nephew, Inc. · Class II
- Permacol — SOFRADIM PRODUCTION · Class II
- XENMATRIX — Davol Inc. · Class II
- Gentrix® — ACELL, INC. · Class II
- Arthrex DX Reinforcement Matrix — DSM BIOMEDICAL, INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Lifecell Corp
Sources (1)
- FDA UDI 74aec03a-ec0f-4600-853f-cea43dab62ba 37 fields · synced Jun 21, 2026