Duns Number:807404611
Catalog Number
1915PG
Brand Name
N/A
Version/Model Number
1915PG
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GAL
Product Code Name
Suture, Absorbable, Natural
Public Device Record Key
f42a8cac-9f6d-444f-8fff-56baaffc84b9
Public Version Date
February 05, 2021
Public Version Number
5
DI Record Publish Date
February 24, 2016
Package DI Number
20790986002160
Quantity per Package
12
Contains DI Package
10790986002163
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 461 |