Duns Number:511268005
Device Description: PREMICRON WHITE 6/0(0,7)45CM 2XHLM8M.RCP
Catalog Number
G2027061
Brand Name
Premicron
Version/Model Number
G2027061
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 26, 2018
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
GAT
Product Code Name
SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
Public Device Record Key
f6568ed4-595a-4cce-b6d6-6a56c2558da9
Public Version Date
February 05, 2021
Public Version Number
7
DI Record Publish Date
August 23, 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 |