FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Tech-Med
DI: 00665973016795
·
Model: 6010-T
·
Dukal LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Tech-Med
- Primary DI
- 00665973016795
- Version / Model
- 6010-T
- Catalog Number
- 6010-T
- Company Name
- Dukal LLC
- Labeler DUNS
- 791014871
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 6
- Public Version Date
- 2022-05-23
- Public Version Status
- Update
- Public Device Record Key
- f6676fd7-0fd0-4aec-acfc-99b3568e63b9
- Distribution End Date
- 2018-11-06
Device Description
GM3A50T Analog TENS
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| GZJ | STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF | Neurology | 882.5890 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35372 | Analgesic transcutaneous electrical nerve stimulation system | An assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20665973016799 | GS1 | Case | 30 | Not in Commercial Distribution | 2018-11-06 |
| Primary | 00665973016795 | GS1 |
Customer Contacts
- Phone
- +1(631)656-3800 ext. 120
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K032720 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 45 | Kilogram |