Identity
- Trade Name
- Integra® FDA UDI
- Generic Name
- Animal-derived wound matrix dressing FDA UDI
- Device Name
- INTEGRA® Meshed Dermal Regeneration Template 4in. x 10in. (10cm x 25cm) FDA UDI
- Model / Reference
- MDRT4101 FDA UDI
- Description
- INTEGRA® Meshed Dermal Regeneration Template 4in. x 10in. (10cm x 25cm) FDA UDI
Identifiers
- Catalog Number
- MDRT4101 FDA UDI
- Primary DI / UDI-DI
- 10381780000648 FDA UDI
- PMA Number
- P900033 FDA UDI
- FDA Product Code
- MGR FDA UDIMDD FDA UDI
- GMDN Term
- Animal-derived wound matrix dressing FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Animal-derived wound matrix dressing
Integra® by Integra Lifesciences Corp. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Animal-derived wound matrix dressing.
- PuraPly™ Antimicrobial XT Wound Matrix — ORGANOGENESIS INC. · Class I
- DermaCol/Ag Healogics by DermaRite — DERMARITE INDUSTRIES LLC · U
- Myriad Matrix™ Soft Tissue Bioscaffold — Aroa Biosurgery · U
- Kerecis® GraftGuide® — KERECIS hf. · U
- HealiAid Collagen Wound Dressing — MAXIGEN BIOTECH INC. · U
- Solventum™ Promogran™ — Solventum US LLC · U
- Simpurity — SAFE N SIMPLE LLC · U
- ProgenaMatrix — Progenacare Global, LLC · U
Cleared under the same submission
P900033 also covers:
- Integra® — Integra Lifesciences Corp.
- Integra® — Integra Lifesciences Corp.
- Integra® — Integra Lifesciences Corp.
- Integra® Dermal Regeneration Template — Integra Lifesciences Corp.
- Integra® Dermal Regeneration Template — Integra Lifesciences Corp.
- Integra® Dermal Regeneration Template — Integra Lifesciences Corp.
- Integra® Dermal Regeneration Template — Integra Lifesciences Corp.
- Integra® Dermal Regeneration Template — Integra Lifesciences Corp.
- Integra® Dermal Regeneration Template — Integra Lifesciences Corp.
- Integra® Dermal Regeneration Template — Integra Lifesciences Corp.
- Integra® Dermal Regeneration Template — Integra Lifesciences Corp.
- Omnigraft™ — Integra Lifesciences Corp.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Integra Lifesciences Corp.
Sources (1)
- FDA UDI 69479c87-abbb-42be-8729-22ec2f732ef3 38 fields · synced May 30, 2026