Duns Number:152165817
Device Description: PuraForce ™ tendon reinforcement matrix is a resorbable collagen based material intended f
Catalog Number
-
Brand Name
PuraForce ™
Version/Model Number
550-004
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
K042809
Product Code
KGN
Product Code Name
Dressing, Wound, Collagen
Public Device Record Key
1fc2ced2-f935-4ee6-bee8-f40db4d8345c
Public Version Date
May 06, 2020
Public Version Number
2
DI Record Publish Date
July 17, 2019
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 |