Identity
- Trade Name
- PuraPly™ Antimicrobial XT Wound Matrix FDA UDI
- Generic Name
- Animal-derived wound matrix dressing FDA UDI
- Device Name
- PuraPly™ Antimicrobial XT Wound Matrix consists of a collagen sheet coated with 0.1% polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds. PuraPly™ Antimicrobial XT Wound Matrix is supplied dry in sheet form. The device is packaged in sterile, sealed single pouches. FDA UDI
- Model / Reference
- 515-034 FDA UDI
- Description
- PuraPly™ Antimicrobial XT Wound Matrix consists of a collagen sheet coated with 0.1% polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds. PuraPly™ Antimicrobial XT Wound Matrix is supplied dry in sheet form. The device is packaged in sterile, sealed single pouches. FDA UDI
Identifiers
- Catalog Number
- 515-034 FDA UDI
- Primary DI / UDI-DI
- 00618474000275 FDA UDI
- FDA Product Code
- KMF FDA UDI
- GMDN Term
- Animal-derived wound matrix dressing FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5090 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
Dimensions & Sizes
- Size
- Width — 5 Centimeter FDA UDILength — 5 Centimeter FDA UDI
Category: Animal-derived wound matrix dressing
PuraPly™ Antimicrobial XT Wound Matrix by Organogenesis Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Animal-derived wound matrix dressing.
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- Simpurity — SAFE N SIMPLE LLC · U
- ProgenaMatrix — Progenacare Global, LLC · U
- INTEGRA® — Integra Lifesciences Corp. · U
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 I | Pending data |
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Manufacturer
- Manufacturer
- Organogenesis Inc.
Sources (1)
- FDA UDI 021653f2-f581-484c-bf49-29ba1fcf20dc 37 fields · synced May 30, 2026