Identity
- Trade Name
- Ease-In-Shields FDA UDI
- Generic Name
- Radiation shielding goggles/spectacles FDA UDI
- Device Name
- Universal Soft Tissue Ease-in-Shields FDA UDI
- Model / Reference
- 5832 FDA UDI
- Description
- Universal Soft Tissue Ease-in-Shields FDA UDI
Identifiers
- Catalog Number
- 5832 FDA UDI
- Primary DI / UDI-DI
- 00883205037428 FDA UDI
- FDA Product Code
- HOY FDA UDI
- GMDN Term
- Radiation shielding goggles/spectacles FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4750 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
Yes
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 goggles/spectacles
Ease-In-Shields by Ultradent Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Ultradent Products, Inc.
Sources (1)
- FDA UDI 5a9c80dd-74aa-474a-b77a-7090f0c23bdb 35 fields · synced May 30, 2026