Duns Number:006261481
Device Description: ENVELOPE NMRM6133 ABSORB LRG MR
Catalog Number
-
Brand Name
TYRX™
Version/Model Number
NMRM6133
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K180122,K192636
Product Code
FTL
Product Code Name
Mesh, surgical, polymeric
Public Device Record Key
ccb539fa-d055-41e1-b0f7-75aa116312ad
Public Version Date
April 12, 2022
Public Version Number
3
DI Record Publish Date
April 06, 2020
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 |