Identity
- Trade Name
- Nike FDA UDI
- Generic Name
- Radiation shielding goggles/spectacles FDA UDI
- Device Name
- BRAZEN GLASSES, BIFOCAL, .75MM PB EQ FDA UDI
- Model / Reference
- EW-0001-BIF FDA UDI
- Description
- BRAZEN GLASSES, BIFOCAL, .75MM PB EQ FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840331296334 FDA UDI
- FDA Product Code
- IWS FDA UDI
- GMDN Term
- Radiation shielding goggles/spectacles 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiation shielding goggles/spectacles
Nike by Burlington Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiation shielding goggles/spectacles.
- Rayshield — AADCO MEDICAL, INC. · Class I
- Rayshield — AADCO MEDICAL, INC. · Class I
- Rayshield — AADCO MEDICAL, INC. · Class I
- Rayshield — AADCO MEDICAL, INC. · Class I
- Rayshield — AADCO MEDICAL, INC. · Class I
- Ease-In-Shields — ULTRADENT PRODUCTS, INC. · Class I
- Rayshield — AADCO MEDICAL, INC. · Class I
- Rayshield — 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
- Burlington Medical, Llc
Sources (1)
- FDA UDI 32b7778f-44e7-4d1d-b141-16c1a2ddb5e4 33 fields · synced May 30, 2026