Duns Number:079402290
Device Description: Violet Braided (Polyglaction 910), Absorbable Surgical Suture
Catalog Number
J4085G
Brand Name
Coated VICRYL
Version/Model Number
J4085G
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K022269,K183183,K022269,K183183
Product Code
GAM
Product Code Name
SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
Public Device Record Key
30ababb6-d74f-4a75-bb33-15b836a80d7c
Public Version Date
March 05, 2021
Public Version Number
1
DI Record Publish Date
February 25, 2021
Package DI Number
30705031467525
Quantity per Package
12
Contains DI Package
10705031467521
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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1028 |
| 3 | A medical device with high risk that requires premarket approval | 15 |
| U | Unclassified | 1 |