Duns Number:017524666
Device Description: UNIFY RPGA Surgical Sutures, Absorbable, 5-0, 11mm 3/8 Circle Rev Cut, 18" Undyed
Catalog Number
-
Brand Name
UNIFY RPGA Surgical Sutures
Version/Model Number
XS-K518R11
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
K183004,K183004,K183004
Product Code
GAM
Product Code Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Public Device Record Key
0d2e47f9-9a5a-4e8c-b616-e363937e979e
Public Version Date
May 03, 2021
Public Version Number
1
DI Record Publish Date
April 23, 2021
Package DI Number
10814639025528
Quantity per Package
12
Contains DI Package
00814639025521
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
bx
| 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 |