Duns Number:006261481
Device Description: ENVELOPE CMRM3133 ANTIBAC LRG US
Catalog Number
-
Brand Name
TYRX™ Antibacterial Envelope - Large
Version/Model Number
CMRM3133
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 14, 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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FTL
Product Code Name
Mesh, surgical, polymeric
Public Device Record Key
319caa94-7b21-48b3-a03c-c32ca654b191
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
June 10, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |