Scleral buckling device, non-bioabsorbable

FDA UDI

Class II (US FDA UDI)

by Fci S A S Fci 20 22

Identity

Trade Name: Scleral buckling device, non-bioabsorbable 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: TIRE 12 TYPE 78 G 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

Catalog Number: S5.1305U FDA UDI
Primary DI / UDI-DI: 03760087121247 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

Dimensions & Sizes

Size: Width — 10 Millimeter FDA UDI
Outer Diameter — 29.6 Millimeter FDA UDI

Category: Scleral buckling device, non-bioabsorbable

Scleral buckling device, non-bioabsorbable 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 6985751b-c80a-4d3e-8523-fce97c0c0cd7 36 fields · synced May 30, 2026