Duns Number:079402290
Device Description: Undyed Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
Catalog Number
YB4946H
Brand Name
MONOCRYL
Version/Model Number
YB4946H
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)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K964072,K964072
Product Code
GAN
Product Code Name
SUTURE, ABSORBABLE, SYNTHETIC
Public Device Record Key
b57e3c89-28cd-49f7-99f8-ca37239cd8b3
Public Version Date
March 01, 2021
Public Version Number
1
DI Record Publish Date
February 19, 2021
Package DI Number
30705031465262
Quantity per Package
36
Contains DI Package
10705031465268
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 |