Identity
- Trade Name
- Symblepharon Ring - 20mm FDA UDI
- Generic Name
- Symblepharon ring, synthetic FDA UDI
- Device Name
- Symblepharon rings are used in order to keep 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
- 14345 FDA UDI
- Description
- Symblepharon rings are used in order to keep 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
- 14345 FDA UDI
- Primary DI / UDI-DI
- B091143450 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 — 20 Millimeter FDA UDI
Symblepharon Ring - 20mm 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 b0d1f12e-fb54-4269-94c3-386e0d2f7cbf 37 fields · synced Jun 8, 2026