Duns Number:796253292
Device Description: PriMatrix Ag 2:1 Meshed 4x4cm
Catalog Number
-
Brand Name
PriMatrix® Ag
Version/Model Number
607-105-440
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K100261,K100261
Product Code
FRO
Product Code Name
Dressing, wound, drug
Public Device Record Key
b9878fdb-affe-4cc3-8264-3baeed87d2e8
Public Version Date
May 06, 2020
Public Version Number
5
DI Record Publish Date
June 22, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 81 |
U | Unclassified | 55 |