Identity
- Trade Name
- Wolf X-Ray, Thyroid Collar Softex FDA UDI
- Generic Name
- Radiation shielding collar FDA UDI
- Device Name
- Thyroid Collar Softex, Medium Blue FDA UDI
- Model / Reference
- 75070-16 FDA UDI
- Description
- Thyroid Collar Softex, Medium Blue FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843696129897 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
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radiation shielding collar
Wolf X-Ray, Thyroid Collar Softex by Flow X-Ray Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- New Style Thyroid Collar — Shielding International Inc. · Class I
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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
- Flow X-Ray Corp.
Sources (1)
- FDA UDI 17381721-27ef-4612-a927-0f9b34c38052 33 fields · synced May 30, 2026