Duns Number:152165817
Device Description: PuraPly™ Antimicrobial Wound Matrix consists of collagen sheets coated with polyhexamethyl PuraPly™ Antimicrobial Wound Matrix consists of collagen sheets 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
515-065
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
a9244a5d-ed35-400a-a563-9bcfc6e4a9e8
Public Version Date
October 12, 2020
Public Version Number
1
DI Record Publish Date
October 02, 2020
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 |