Scleral buckling device, non-bioabsorbable

Basic Information

• Brand Name: Scleral buckling device, non-bioabsorbable
• Primary DI: 03760087127355
• Version / Model: SPONGE 7.0 x 3.25 TYPE 907
• Catalog Number: S5.6585U
• Company Name: FCI S A S FCI 20 22
• Labeler DUNS: 763408366
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2020-02-25
• Public Version: 3
• Public Version Date: 2021-12-22
• Public Version Status: Update
• Public Device Record Key: cfbaa2a0-2e7f-45de-952f-f72719ba32d0
• Distribution End Date: 2021-04-28

Device 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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HQX	Implant, Orbital, Extra-Ocular	Ophthalmic	886.3340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42545	Scleral buckling device, non-bioabsorbable	A 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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	53760087127350	GS1
Primary	03760087127355	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	100	Millimeter
Width	7	Millimeter
Height	3.25	Millimeter