Duns Number:017524666
Device Description: UNIFY PGA Surgical Sutures, Absorbable, 4-0, 19mm 3/8 Cir, R/C Violet, 18"3 DZN Pack
Catalog Number
-
Brand Name
UNIFY PGA Surgical Sutures
Version/Model Number
M-G418XR19
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
-
Product Code
GAM
Product Code Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Public Device Record Key
55a99d96-20cb-48a5-8616-ac2411210103
Public Version Date
May 05, 2021
Public Version Number
1
DI Record Publish Date
April 27, 2021
Package DI Number
10814639025597
Quantity per Package
36
Contains DI Package
00814639025590
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 |