Duns Number:511268005
Device Description: MONOMAX VLT 0 (3,5) 90CM HR37S USA(M)
Catalog Number
B9941129
Brand Name
Monomax
Version/Model Number
B9941129
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 24, 2016
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
NWJ
Product Code Name
Suture, recombinant technology
Public Device Record Key
6c8c1a24-e17c-4ed6-aacc-a32698153fd4
Public Version Date
March 26, 2021
Public Version Number
7
DI Record Publish Date
November 01, 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 |