Identity
- Trade Name
- HALF-SPONGE 2.75 X 7.5 TYPE 511 FDA UDI
- Generic Name
- Scleral buckling device, non-bioabsorbable FDA UDI
- Device Name
- A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buckling for the surgical treatment of retinal detachment. It is typically a moulded solid silicone or silicone sponge device available in a variety of shapes and sizes that is used to compress the retina long-term (up to months) to support its reattachment following the operative treatment of severe retinal detachment. This device, also known as a scleral buckling component, will occupy the intraocular space to provide compression against the retina so that it can reattach. It is typically removed after a period of time depending upon the clinical findings. FDA UDI
- Model / Reference
- S5.6475 FDA UDI
- Description
- A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buckling for the surgical treatment of retinal detachment. It is typically a moulded solid silicone or silicone sponge device available in a variety of shapes and sizes that is used to compress the retina long-term (up to months) to support its reattachment following the operative treatment of severe retinal detachment. This device, also known as a scleral buckling component, will occupy the intraocular space to provide compression against the retina so that it can reattach. It is typically removed after a period of time depending upon the clinical findings. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03760087121971 FDA UDI
- FDA Product Code
- HQX FDA UDI
- GMDN Term
- Scleral buckling device, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.3340 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Scleral buckling device, non-bioabsorbable
Half-Sponge 2.75 X 7.5 Type 511 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 Scleral buckling device, non-bioabsorbable.
- Scleral Buckling Product Style 505T, 5.0mm Round Tunel Sponge — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
- MIRA IMEX Scleral Buckling Component — MIRA, INC. · Class II
- MIRA IMEX Scleral Buckling Component — MIRA, INC. · Class II
- Scleral Buckling Products: Style 41, 3.5mm Silicone Strip — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
- MIRA IMEX Scleral Buckling Component — MIRA, INC. · Class II
- Scleral Buckling Products: Style 289, Convex Tire — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
- MIRA IMEX Scleral Buckling Component — MIRA, INC. · Class II
- MIRA IMEX Scleral Buckling Component — MIRA, 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
- Fci S A S Fci 20 22
Sources (1)
- FDA UDI c0c85a8c-de39-4d12-84be-f1b4156e4acd 33 fields · synced May 30, 2026