HALF-SPONGE 2.75 X 7.5 TYPE 511

GUDID 33760087121972

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.

FCI S A S FCI 20 22

Scleral buckling device, non-bioabsorbable Scleral buckling device, non-bioabsorbable Scleral buckling device, non-bioabsorbable Scleral buckling device, non-bioabsorbable Scleral buckling device, non-bioabsorbable Scleral buckling device, non-bioabsorbable Scleral buckling device, non-bioabsorbable Scleral buckling device, non-bioabsorbable Scleral buckling device, non-bioabsorbable Scleral buckling device, non-bioabsorbable Scleral buckling device, non-bioabsorbable Scleral buckling device, non-bioabsorbable Scleral buckling device, non-bioabsorbable Scleral buckling device, non-bioabsorbable

• Primary Device ID: 33760087121972
• NIH Device Record Key: c0c85a8c-de39-4d12-84be-f1b4156e4acd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HALF-SPONGE 2.75 X 7.5 TYPE 511
• Version Model Number: S5.6475
• Company DUNS: 763408366
• Company Name: FCI S A S FCI 20 22
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760087121971 [Primary]
GS1	33760087121972 [Package]; Contains: 03760087121971; Package: [3 Units]; In Commercial Distribution

FDA Product Code

• HQX: Implant, Orbital, Extra-Ocular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-12-22
• Device Publish Date: 2021-05-30

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