Identity
- Trade Name
- UniRay FDA UDI
- Generic Name
- Radiation shielding collar FDA UDI
- Device Name
- Thyroid Collar with magnetic closure - 0.35mm MaxLite FDA UDI
- Model / Reference
- UF551200 FDA UDI
- Description
- Thyroid Collar with magnetic closure - 0.35mm MaxLite FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08904333250519 FDA UDI
- FDA Product Code
- KPY FDA UDI
- GMDN Term
- Radiation shielding collar 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: Radiation shielding collar
UniRay by Uniray Medical Llp — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiation shielding collar.
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- Wolf X-Ray, Thyroid Collar Softex — Flow X-Ray Corp. · Class I
- ComfortLite — AADCO MEDICAL, INC. · Class I
- MindPeace — Texray AB · Class I
- New Style Thyroid Collar — Shielding International Inc. · Class I
- Wolf X-Ray, Thyroid Collar Softex — Flow X-Ray Corp. · 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 |
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Manufacturer
- Manufacturer
- Uniray Medical Llp
Sources (1)
- FDA UDI aead01df-a7ce-4fa6-819f-afc4f3d02659 33 fields · synced Jun 1, 2026