Duns Number:796986144
Device Description: COMM HANDSET KIT TH91D01 DBS A10E PPR EN
Catalog Number
-
Brand Name
N/A
Version/Model Number
TH91D01
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
P960009,H050003,H020007
Product Code
MBX
Product Code Name
STIMULATOR, THALAMIC, EPILEPSY, IMPLANTED
Public Device Record Key
353eb20e-f150-423f-a3f5-f4426bd1b370
Public Version Date
April 26, 2021
Public Version Number
1
DI Record Publish Date
April 18, 2021
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 |