FDA UDI
In Commercial Distribution
🇺🇸 United States
BioStimul Handpiece
DI: 08034108512419
·
Model: N378C1
·
DEKA M.E.L.A. SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- BioStimul Handpiece
- Primary DI
- 08034108512419
- Version / Model
- N378C1
- Company Name
- DEKA M.E.L.A. SRL
- Labeler DUNS
- 629381096
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-16
- Public Version
- 2
- Public Version Date
- 2025-04-18
- Public Version Status
- Update
- Public Device Record Key
- dd8c96f8-2308-45a0-949d-8f46e0857149
Device Description
The BioStimul Handpiece is intended to emit energy in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief/reduction of minor muscolar and joint pain and stiffness, minor arthrits pain or muscle spasm, the temporary increase in local blood circulation, and temporary relaxation of muscles. The spot diameter at 1 cm out of the handpiece is 5 mm. The BioStimul Handpiece is supplied together with a suitable optical fiber.
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
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| ILY | Lamp, Infrared, Therapeutic Heating | Physical Medicine | 890.5500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35147 | Musculoskeletal infrared phototherapy unit, non-wearable | An electrically-powered device intended for use in the home or clinical setting to provide a source of infrared (IR) heat for localized treatment of musculoskeletal pain/injury (e.g., muscle pain, sports injury, rheumatism) and to improve blood circulation in the treated areas to facilitate healing. It may be available in a variety of forms however it is not intended to be worn on the body. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08034108512419 | GS1 |