FDA UDI
In Commercial Distribution
🇺🇸 United States
POINTER PAL
DI: 14897076720221
·
Model: Pt.Pal
·
TENS PLUS INDUSTRIAL COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- POINTER PAL
- Primary DI
- 14897076720221
- Version / Model
- Pt.Pal
- Company Name
- TENS PLUS INDUSTRIAL COMPANY
- Labeler DUNS
- 663211978
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-14
- Public Version
- 1
- Public Version Date
- 2022-11-22
- Public Version Status
- New
- Public Device Record Key
- 3bb8840a-6f69-4cbe-84f4-74ddbc4ac673
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| BWJ | Locator, Acupuncture Point | General Hospital | 880.5580 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34497 | Acupuncture point detector | An electronic probe used to precisely locate an acupuncture point on a patient's body. It is used in complementary medicine therapy either independently or with a device intended to apply stimuli to acupuncture sites (e.g., an electrical stimulator). It may include visual or audio signals to indicate the acupuncture point. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 14897076720221 | GS1 |