FDA UDI
In Commercial Distribution
🇺🇸 United States
BIOS Living
DI: 00057475277314
·
Model: LG731
·
Thermor Ltd
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- BIOS Living
- Primary DI
- 00057475277314
- Version / Model
- LG731
- Company Name
- Thermor Ltd
- Labeler DUNS
- 246883458
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-18
- Public Version
- 2
- Public Version Date
- 2023-12-13
- Public Version Status
- Update
- Public Device Record Key
- 579f4bdb-84b1-4f91-bdff-99ec1b915940
Device Description
Extendable Massage Roller
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
- No
- 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 |
|---|---|---|---|---|
| LYG | Massager, Therapeutic, Manual | Physical Medicine | 890.5660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34661 | External manual massager, home-use | A manual (non-powered) device specifically designed to apply external massage in the home. It is typically held in the hand of the user and drawn/rolled across the area of the body/muscles to be treated; it may also be designed to be placed on the floor for foot massage. The massaging components, e.g., roller heads or pads, may be interchangeable with others of different size and shape. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20057475277318 | GS1 | Case | 12 | In Commercial Distribution | |
| Primary | 00057475277314 | GS1 | ||||
| Package | 10057475277311 | GS1 | Case | 2 | In Commercial Distribution | |
| Package | 00057475773144 | GS1 | Display | 12 | In Commercial Distribution |