PuraPly™ Antimicrobial Wound Matrix 1
PuraPly™ Antimicrobial Wound Matrix 1 is a device classified as Unclassified made by Organogenesis Inc., cleared under FDA 510(k) K051647 on 8 Nov 2005 and listed in FDA GUDID since 22 May 2015 (UDI-DI 00618474000039), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00618474000039 | Date22 May 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK051647 | Date8 Nov 2005 | StatusActive |
Official records
- AccessGUDID record 00618474000039
- FDA 510(k) database K051647
Across registries
- FDA 510(k) K051647 decided 8 Nov 2005 Active
- FDA GUDID UDI-DI 00618474000039 listed 22 May 2015 Listed
Timeline
- Cleared FDA 510(k) K051647
- Listed FDA GUDID 00618474000039
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- PuraPly™ Antimicrobial Wound Matrix
- Generic name
- Animal-derived wound matrix dressing
- Model / reference
- 1
- Primary DI / UDI-DI
- 00618474000039
- 510(k) Number
- FDA product code
- FRO
- GMDN term
- Animal-derived wound matrix dressing
- Device class
- U
- GUDID distribution status
- Not in Commercial Distribution
- Size
- Area/Surface Area — 4 Square centimeterArea/Surface Area — 54 Square centimeterArea/Surface Area — 8 Square centimeterArea/Surface Area — 25 Square centimeter