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: SPONGE 7.0 x 3.25 TYPE 907 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: S5.6585U FDA UDI
Primary DI / UDI-DI: 03760087127355 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: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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Implantable

Yes

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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

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Serial Number

Yes

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Expiration Date

Yes

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Manufacturing Date

Yes

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Sterilization Method

Radiation Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 100 Millimeter FDA UDI
Width — 7 Millimeter FDA UDI
Height — 3.25 Millimeter FDA UDI

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

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 cfbaa2a0-2e7f-45de-952f-f72719ba32d0 37 fields · synced May 30, 2026