Duns Number:017524666
Device Description: Premium Polypropylene, Med 5-0, 19mm 3/8 circle Rev Cut, 18"
Catalog Number
-
Brand Name
Premium UNIFY PP Sutures
Version/Model Number
PMP-518R19
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K000537,K080684,K000537,K080684,K000537,K080684
Product Code
GAW
Product Code Name
Suture, Nonabsorbable, Synthetic, Polypropylene
Public Device Record Key
805c1821-9119-4e42-a9b3-21f5c1d88d00
Public Version Date
February 05, 2021
Public Version Number
5
DI Record Publish Date
November 09, 2016
Package DI Number
20814639022418
Quantity per Package
100
Contains DI Package
10814639022411
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 73 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 121 |