Duns Number:017524666
Device Description: Premium Polypropylene, 4-0, 24mm 3/8 circle Rev Cut, 27"
Catalog Number
-
Brand Name
Premium UNIFY PP Sutures
Version/Model Number
PLP-427R24
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
Product Code
GAW
Product Code Name
Suture, Nonabsorbable, Synthetic, Polypropylene
Public Device Record Key
5c3323c0-a07e-4d1e-9e3e-87e8eb17b4e9
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
August 03, 2020
Package DI Number
10814639023739
Quantity per Package
12
Contains DI Package
00814639023732
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |