Duns Number:152165817
Device Description: PuraPly™ Wound Matrix consists of a single-layer fenestrated sheet of collagen intended fo PuraPly™ Wound Matrix consists of a single-layer fenestrated sheet of collagen intended for the management of wounds. PuraPly™ Wound Matrix is supplied dry in sheet form. The device is packaged in sterile, sealed single pouches.
Catalog Number
-
Brand Name
PuraPly™ Wound Matrix
Version/Model Number
515-010
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K011026,K011026
Product Code
KGN
Product Code Name
Dressing, Wound, Collagen
Public Device Record Key
8889da13-277d-4628-9d14-d63f2b6a7bed
Public Version Date
May 06, 2020
Public Version Number
4
DI Record Publish Date
March 24, 2016
Package DI Number
00618474000138
Quantity per Package
3
Contains DI Package
00618474000053
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Market Unit Box
| 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 |