Duns Number:017524666
Device Description: Premium UNIFY Chromic Sutures Med 5-0, 16mm 3/8 Circle Rev Cut, 18"
Catalog Number
-
Brand Name
Premium UNIFY Chromic Sutures
Version/Model Number
PMC-518R16
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K000542,K000542,K000542
Product Code
GAL
Product Code Name
Suture, Absorbable, Natural
Public Device Record Key
8c353de0-c85c-455c-816d-91de06916fad
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
10814639022794
Quantity per Package
12
Contains DI Package
00814639022797
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 |