FDA UDI
In Commercial Distribution
🇺🇸 United States
TB12 VIBRATING PLIABILITY ROLLER
DI: 04580657301003
·
Model: VPLI-RED-02A
·
DREAM FACTORY INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- TB12 VIBRATING PLIABILITY ROLLER
- Primary DI
- 04580657301003
- Version / Model
- VPLI-RED-02A
- Company Name
- DREAM FACTORY INC.
- Labeler DUNS
- 698505802
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-06
- Public Version
- 1
- Public Version Date
- 2021-01-14
- Public Version Status
- New
- Public Device Record Key
- 0829c3c4-942c-4113-b1e1-cb6e447a86f5
Device Description
Offers people of all ages, gender and abilities the benefits to improve the body’s overall performance, flexibility, and range of motion to prevent injury and thus improve overall well being.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ISA | Massager, Therapeutic, Electric | Physical Medicine | 890.5660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36560 | Hand-held electric massager | An electrically-powered device with a vibrating head, or pads, designed to be held in the hand and drawn across the area of the body/muscles to be treated. The vibrating head, or pads, may optionally be heated, and may be interchangeable with others of different size and shape. It is typically used for respiratory therapy or physiotherapy (e.g., help reduce muscular tension, arthritic pain or joint mobility) in the home and/or healthcare facility. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04580657301003 | GS1 |