Duns Number:796986144
Device Description: ANTENNA 37092 ITRL4 MRI W/AR W/O INTRCPT
Catalog Number
-
Brand Name
NA
Version/Model Number
37092
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
-
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
H020007,H050003,P080025,P840001,P860004,P960009,P970004
Product Code
EZW
Product Code Name
Stimulator, electrical, implantable, for incontinence
Public Device Record Key
cd7de73e-bc68-4c40-884f-4bdb6402bf87
Public Version Date
July 07, 2020
Public Version Number
5
DI Record Publish Date
December 08, 2017
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 |