FDA UDI
In Commercial Distribution
🇺🇸 United States
Therapist’s Choice®
DI: 00815290015593
·
Model: TC120R
·
CLINICAL HEALTH SERVICES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- Therapist’s Choice®
- Primary DI
- 00815290015593
- Version / Model
- TC120R
- Catalog Number
- TC120R
- Company Name
- CLINICAL HEALTH SERVICES, INC.
- Labeler DUNS
- 004416769
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-19
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- c0eada14-3937-4c63-b197-8b439ba48794
Device Description
TC120R- 2" Round" electrodes, white cloth, carbon, plastic zip lock
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GXY | Electrode, Cutaneous | Neurology | 882.1320 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35751 | Transcutaneous electrical stimulation lead | A non-sterile, insulated, electrical conducting wire intended to be used to connect a transcutaneous electrical stimulation electrode to an electrical stimulus generator (e.g., TENS system generator), or a wire having a distal end that splits and terminates as electrodes which are placed on the patient for the transmission of electrical stimulation. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00815290015623 | GS1 | master case | 5 | In Commercial Distribution | |
| Package | 00815290015616 | GS1 | inner box | 10 | In Commercial Distribution | |
| Package | 00815290015609 | GS1 | poly bag | 10 | In Commercial Distribution | |
| Primary | 00815290015593 | GS1 |
Customer Contacts
- Phone
- 813-871-3120
- [email protected]