Duns Number:511268005
Device Description: MONOSYN UNDYED 4/0 (1,5) 45CM DGMP19 DDP
Catalog Number
G0023704
Brand Name
Monosyn
Version/Model Number
G0023704
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)
-
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
81b88d47-cf7a-4e3c-abde-287809414b28
Public Version Date
February 05, 2021
Public Version Number
7
DI Record Publish Date
November 12, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 13 |