Duns Number:511268005
Device Description: PREMILENE 6/0 (0.7) 60CM 2XDRC8 CV
Catalog Number
C2090172
Brand Name
Premilene
Version/Model Number
C2090172
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 22, 2015
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
GAW
Product Code Name
SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
Public Device Record Key
846f2f02-bee8-48a7-9ed0-34aec9fa2a7f
Public Version Date
March 29, 2021
Public Version Number
7
DI Record Publish Date
August 17, 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 |