Duns Number:796986144
Device Description: COMM HANDSET KIT TH91D01 DBS US PPR EN
Catalog Number
-
Brand Name
NA
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
H050003,H020007,P960009
Product Code
MHY
Product Code Name
Stimulator, electrical, implanted, for parkinsonian tremor
Public Device Record Key
cf0b74a4-a4e6-4795-a95f-2ec89637875c
Public Version Date
July 13, 2020
Public Version Number
1
DI Record Publish Date
July 05, 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 |