Identity
- Trade Name
- Symblepharon Ring Conformer Large FDA UDI
- Generic Name
- Symblepharon ring, synthetic FDA UDI
- Device Name
- The Symblepharon rings are used to prevent retraction of the conjunctiva cul-de-sac. The ring is inserted between the eye and the lid and is supported by the sclera without touching the cornea. The purpose of the Symblepharon Rings is to avoid tissue adhesion after excision of the symblepharon. The ring has a center hole to enable the patient to see. The surfaces are polished in order to avoid any abrasion of the cornea or ocular globe. The Symblepharon Rings are medical devices made of acrylic (PMMA). They must not be autoclaved, otherwise they will be damaged: ethylene oxide sterilization is recommended. The devices' family has different sizes (small, medium, large). FDA UDI
- Model / Reference
- 21-416 FDA UDI
- Description
- The Symblepharon rings are used to prevent retraction of the conjunctiva cul-de-sac. The ring is inserted between the eye and the lid and is supported by the sclera without touching the cornea. The purpose of the Symblepharon Rings is to avoid tissue adhesion after excision of the symblepharon. The ring has a center hole to enable the patient to see. The surfaces are polished in order to avoid any abrasion of the cornea or ocular globe. The Symblepharon Rings are medical devices made of acrylic (PMMA). They must not be autoclaved, otherwise they will be damaged: ethylene oxide sterilization is recommended. The devices' family has different sizes (small, medium, large). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10697660002382 FDA UDI
- FDA Product Code
- HQN FDA UDI
- GMDN Term
- Symblepharon ring, synthetic 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
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 24 Millimeter FDA UDI
Category: Symblepharon ring, synthetic
Symblepharon Ring Conformer Large by Oculo-Plastik Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Symblepharon ring, synthetic.
- SYMBLEPHARON RING 22 MM — FCI S A S FCI 20 22 · Class II
- SYMBLEPHARON RING 20 MM — FCI S A S FCI 20 22 · Class II
- SYMBLEPHARON RING 25 MM — FCI S A S FCI 20 22 · Class II
- Symblepharon Ring Conformer Small — Oculo-Plastik Inc · Class II
- Symblepharon Ring Conformer Medium — Oculo-Plastik 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
- Oculo-Plastik Inc
Sources (1)
- FDA UDI cf8e0a02-fbaf-406b-9c84-6c9c44dc9765 35 fields · synced May 30, 2026