FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 00763000424107
·
Model: TH90D01
·
MEDTRONIC, INC.
Product Codes
6
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- N/A
- Primary DI
- 00763000424107
- Version / Model
- TH90D01
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 006261481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-18
- Public Version
- 2
- Public Version Date
- 2025-12-17
- Public Version Status
- Update
- Public Device Record Key
- 835b13b8-4b58-4169-8bc4-57ea151cc22f
Device Description
COMM HANDSET KIT TH90D01 DBS A10E PPR EN
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MRU | implanted subcortical electrical Stimulator (motor disorders) | Unknown | f | |
| MHY | Stimulator, electrical, implanted, for parkinsonian tremor | Unknown | 3 | |
| MBX | STIMULATOR, THALAMIC, EPILEPSY, IMPLANTED | Unknown | 3 | |
| OLM | Deep brain stimulator for obsessive compulsive disorder (OCD) | Unknown | f | |
| NHL | Stimulator, electrical, implanted, for parkinsonian symptoms | Unknown | 3 | |
| PJS | Stimulator, electrical, implanted, for essential tremor | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61393 | Multiple active implantable device programmer | An external, portable, non-dedicated, electrically-powered device intended to change, noninvasively (i.e., wirelessly), the operating parameters (programs) of multiple types of implanted electronic devices (e.g., multiple types of pulse generators); it may in addition program the external trial device used prior to the implanted one. It includes controls (e.g., graphical user interface), integrated software, and a wireless communication transmitter and receiver. It typically also provides historic and/or current information regarding the performance of the implant. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00763000424107 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| H020007 | 257 |
| H050003 | 226 |
| P960009 | 361 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -35 – 58 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -31 – 136 Degrees Fahrenheit