Duns Number:042763706
Device Description: PuraPLUG 10x20mm, 10/BX Collagen Dental Dressing
Catalog Number
PGPLG1
Brand Name
REGENX PuraTAPE
Version/Model Number
PGPLG1
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
-
Product Code
KGN
Product Code Name
Dressing, Wound, Collagen
Public Device Record Key
d563be56-ca05-4f69-8de0-69d3d3d4f72a
Public Version Date
July 07, 2020
Public Version Number
3
DI Record Publish Date
December 15, 2016
Package DI Number
10614950008718
Quantity per Package
10
Contains DI Package
00614950008711
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1288 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 943 |
| U | Unclassified | 6 |