Identity
- Trade Name
- UniRay FDA UDI
- Generic Name
- Partial-hand radiation shield FDA UDI
- Device Name
- Mittens (Full coverage) / pair, 0.35mm FDA UDI
- Model / Reference
- UFGM1201 FDA UDI
- Description
- Mittens (Full coverage) / pair, 0.35mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08904333250571 FDA UDI
- FDA Product Code
- IWP FDA UDI
- GMDN Term
- Partial-hand radiation shield FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.6500 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Partial-hand radiation shield
UniRay by Uniray Medical Llp — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Partial-hand radiation shield.
- AADCO — AADCO MEDICAL, INC. · Class I
- AADCO — AADCO MEDICAL, INC. · Class I
- AADCO — AADCO MEDICAL, INC. · Class I
- AADCO — AADCO MEDICAL, INC. · Class I
- AADCO — AADCO MEDICAL, INC. · Class I
- AADCO — AADCO MEDICAL, INC. · Class I
- AADCO — AADCO MEDICAL, INC. · Class I
- AADCO — AADCO MEDICAL, INC. · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Uniray Medical Llp
Sources (1)
- FDA UDI b12d4f99-89f4-4980-b1b5-97b9b8694807 33 fields · synced May 30, 2026