Identity
- Trade Name
- Silicone Conformer FDA UDI
- Generic Name
- Ophthalmic conformer FDA UDI
- Model / Reference
- Medium FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00854428006355 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
Category: Ophthalmic conformer
Silicone Conformer by Jardon Eye Prosthetics, Inc. — 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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- Small Conformer (non-sterile) — Gulden Ophthalmics · Class II
- Ambler Surgical — Ambler Surgical, LLC · Class II
- Bio-Eye® — INTEGRATED ORBITAL IMPLANTS, 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
- Jardon Eye Prosthetics, Inc.
Sources (1)
- FDA UDI 057b6792-a8c5-49cb-bb47-251a76cbfa91 32 fields · synced Jun 8, 2026