Identity
- Trade Name
- MSI Precision Specialty Instruments FDA UDI
- Generic Name
- Ophthalmic conformer FDA UDI
- Device Name
- Silicone Eye Conformer, 15mm-17mm FDA UDI
- Model / Reference
- 19-17 FDA UDI
- Description
- Silicone Eye Conformer, 15mm-17mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00194613026158 FDA UDI
- FDA Product Code
- HOY FDA UDI
- GMDN Term
- Ophthalmic conformer 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ophthalmic conformer
MSI Precision Specialty Instruments by Med Saver, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic conformer.
- Bilateral Conformer 22 Small — Oculo-Plastik Inc · Class II
- SILICONE CONFORMER (FLEXIBLE) — FCI S A S FCI 20 22 · Class II
- Small Conformer (non-sterile) — Gulden Ophthalmics · Class II
- 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
- Small Sterile Eye Conformer (PMMA) — Gulden Ophthalmics · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Med Saver, Inc.
Sources (1)
- FDA UDI c581d1c2-c292-45cd-a144-894c26c20dbc 34 fields · synced May 30, 2026