FDA UDI
In Commercial Distribution
🇺🇸 United States
Luminance RED Tip
DI: 00860002593074
·
Model: BE-NQUQ-FSF8
·
Luminance Medical Ventures Incorporated
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Luminance RED Tip
- Primary DI
- 00860002593074
- Version / Model
- BE-NQUQ-FSF8
- Company Name
- Luminance Medical Ventures Incorporated
- Labeler DUNS
- 065554288
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-26
- Public Version
- 1
- Public Version Date
- 2023-06-05
- Public Version Status
- New
- Public Device Record Key
- eafab351-be6d-4183-9384-fc76a0d0d6b4
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
- 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
- Yes
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 |
|---|---|---|---|---|
| 63540 | Musculoskeletal/physical therapy laser beam guide, transcutaneous | A noninvasive, hand-held device intended to be connected to a laser unit intended for musculoskeletal therapy [e.g., infrared phototherapy laser, low-level laser therapy (LLLT) system] to deliver visible red/infrared laser light energy to the skin-surface for localized treatment of underlying musculoskeletal pain/injury (e.g., muscle pain, sports injury, rheumatism) and to improve blood circulation in the treated areas to facilitate healing. It is a handpiece-like device with fibreoptic materials and may include a manual massager as an adjunct to laser energy therapy. It is intended to be operated by a healthcare professional exclusively in a clinical setting. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860002593074 | GS1 |