Duns Number:152165817
Device Description: PuraPly™ Antimicrobial Wound Matrix consists of a collagen sheet coated with polyhexamethy PuraPly™ Antimicrobial Wound Matrix consists of a collagen sheet coated with polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds. PuraPly™ Antimicrobial Wound Matrix is supplied dry in sheet form. The device is packaged in sterile, sealed pouches.
Catalog Number
-
Brand Name
PuraPly™ Antimicrobial Wound Matrix
Version/Model Number
515-020
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K051647
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
783c8a02-6d7f-4a08-8d6c-3eab18a66877
Public Version Date
May 06, 2020
Public Version Number
4
DI Record Publish Date
November 16, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 19 |