Duns Number:079402290
Device Description: Violet Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
Catalog Number
Y922H
Brand Name
MONOCRYL
Version/Model Number
Y922H
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
K960653,K960653
Product Code
GAM
Product Code Name
SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
Public Device Record Key
d117ae55-f63c-4ac1-b9a8-aa9006c8a5bb
Public Version Date
July 14, 2022
Public Version Number
6
DI Record Publish Date
September 01, 2015
Package DI Number
30705031059850
Quantity per Package
36
Contains DI Package
10705031059856
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 |