Identity
- Trade Name
- GameDay FDA UDI
- Generic Name
- Musculoskeletal infrared phototherapy unit, non-wearable FDA UDI
- Model / Reference
- Gameday Laser FDA UDI
Identifiers
- Catalog Number
- U300-200 FDA UDI
- Primary DI / UDI-DI
- 00852556007107 FDA UDI
- 510(k) Number
- K080102 FDA UDI
- FDA Product Code
- ILY FDA UDI
- GMDN Term
- Musculoskeletal infrared phototherapy unit, non-wearable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Musculoskeletal infrared phototherapy unit, non-wearable
GameDay by Multi Radiance Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K080102 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Multi Radiance Medical
Sources (1)
- FDA UDI 1ce8b98d-7624-4dad-97bd-a2953d6a11f9 34 fields · synced Jun 8, 2026