Identity
- Trade Name
- Ophthalmic Conformer FDA UDI
- Generic Name
- Ophthalmic conformer FDA UDI
- Model / Reference
- V2628 FDA UDI
Identifiers
- Catalog Number
- D120810 FDA UDI
- Primary DI / UDI-DI
- G290V2628 FDA UDI
- FDA Product Code
- HQN FDA UDI
- GMDN Term
- Ophthalmic conformer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.3130 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ophthalmic conformer
Ophthalmic Conformer by Midwest Eye Laboratories Woodbury Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ophthalmic conformer.
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- Ambler Surgical — Ambler Surgical, LLC · Class II
- Bio-Eye® — INTEGRATED ORBITAL IMPLANTS, INC. · Class II
- Silicone Conformer — JARDON EYE PROSTHETICS, INC. · Class II
- PROKERA® — BioTissue Holdings Inc. · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Midwest Eye Laboratories Woodbury Llc
Sources (1)
- FDA UDI a49b45f9-4bc3-46f9-ad45-4c056495fbe9 35 fields · synced May 31, 2026