Identity
- Trade Name
- FRESNEL PRISM AND LENS FDA UDI
- Generic Name
- Vision physiology/eye movement analysis system FDA UDI
- Device Name
- FOIL BAR, BANGERTER FDA UDI
- Model / Reference
- 6300-B FDA UDI
- Description
- FOIL BAR, BANGERTER FDA UDI
Identifiers
- Catalog Number
- 6300-B FDA UDI
- Primary DI / UDI-DI
- 00850029104650 FDA UDI
- FDA Product Code
- NXR FDA UDI
- GMDN Term
- Vision physiology/eye movement analysis system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1290 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vision physiology/eye movement analysis system
Fresnel Prism And Lens by Fresnel Prism & Lens Co. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vision physiology/eye movement analysis system.
- RightEye Vision System — Righteye, LLC · Class II
- Interacoustics — Interacoustics A/S · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class I
- EYE-SYNC — NEUROSYNC, INC. · Class II
- VT1 Junior SH — FIM Medical · Class I
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class I
- Interacoustics — Interacoustics A/S · Class II
- VT1 DMV-D — FIM Medical · 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
- Fresnel Prism & Lens Co.
Sources (1)
- FDA UDI d8d70922-606d-4482-b3fc-d1f0f14fc314 36 fields · synced Jun 6, 2026