Duns Number:017524666
Device Description: Premium PGA Suture, Size 0, 40mm 1/2 Cir Taper Point, Violet, 27"
Catalog Number
-
Brand Name
Premium UNIFY PGA Sutures
Version/Model Number
PXXL-G027T40
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 26, 2021
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
K073614,K161629,K200392,K073614,K161629,K200392
Product Code
GAM
Product Code Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Public Device Record Key
b0c9a50c-d236-4a1f-93ec-3e9eadc288a2
Public Version Date
April 27, 2021
Public Version Number
6
DI Record Publish Date
August 13, 2018
Package DI Number
10814639023890
Quantity per Package
12
Contains DI Package
00814639023893
Package Discontinue Date
April 26, 2021
Package Status
Not 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 |