Duns Number:511268005
Device Description: CATGUT CHROM 0 (4) 75CM DR32
Catalog Number
B0561495
Brand Name
Catgut
Version/Model Number
B0561495
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 12, 2021
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
GAL
Product Code Name
SUTURE, ABSORBABLE, NATURAL
Public Device Record Key
c3f7b36d-7a46-4f35-ab49-b734b88ea35a
Public Version Date
October 13, 2021
Public Version Number
5
DI Record Publish Date
August 05, 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 |