Identity
- Trade Name
- Symblepharon Ring - 22mm FDA UDI
- Generic Name
- Symblepharon ring, synthetic FDA UDI
- Device Name
- Symblepharon rings are effective in keeping ocular fornices formed after surgery, in situations where conjunctival cicatricial disease is present, or after ocular trauma such as chemical burns or avulsion of the conjunctiva. The ring prevent adhesions and shortening or retraction of the fornices and cul-de-sacs without touching the cornea. FDA UDI
- Model / Reference
- 14346 FDA UDI
- Description
- Symblepharon rings are effective in keeping ocular fornices formed after surgery, in situations where conjunctival cicatricial disease is present, or after ocular trauma such as chemical burns or avulsion of the conjunctiva. The ring prevent adhesions and shortening or retraction of the fornices and cul-de-sacs without touching the cornea. FDA UDI
Identifiers
- Catalog Number
- 14346 FDA UDI
- Primary DI / UDI-DI
- B091143460 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
- Not 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
Dimensions & Sizes
- Size
- Outer Diameter — 22 Millimeter FDA UDI
Symblepharon Ring - 22mm by Gulden Ophthalmics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Gulden Ophthalmics
Sources (1)
- FDA UDI aa9d553d-1309-450a-8811-b847785a4b3a 37 fields · synced Jun 8, 2026