Identity
- Trade Name
- SILICONE CONFORMER (FLEXIBLE) FDA UDI
- Generic Name
- Ophthalmic conformer FDA UDI
- Device Name
- An ophthalmic device, typically constructed from moulded plastic, that is intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following eye surgery. This is a single-use device. FDA UDI
- Model / Reference
- S6.2001 FDA UDI
- Description
- An ophthalmic device, typically constructed from moulded plastic, that is intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following eye surgery. This is a single-use device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03760087122589 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
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ophthalmic conformer
Silicone Conformer (flexible) by Fci S A S Fci 20 22 — Class II — 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
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- 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
- MSI Precision Specialty Instruments — Med Saver, 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 II | Pending data |
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Manufacturer
- Manufacturer
- Fci S A S Fci 20 22
Sources (1)
- FDA UDI 9068b761-a168-490e-a2c9-fe8f06746d31 33 fields · synced Jun 8, 2026