Scleral buckling device, non-bioabsorbable S5.1105U

GUDID 53760087121198

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

Primary Device ID	53760087121198
NIH Device Record Key	9152ccd1-b723-4f4e-b722-067d76df7c05
Commercial Distribution Status	In Commercial Distribution
Brand Name	Scleral buckling device, non-bioabsorbable
Version Model Number	STRIP (5.7 mm) TYPE 20
Catalog Number	S5.1105U
Company DUNS	763408366
Company Name	FCI S A S FCI 20 22
Device Count	5
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

Customer Support Contacts

Phone	800-932-4202
Email	orders@fci-ophthalmics.com
Phone	800-932-4202
Email	orders@fci-ophthalmics.com
Phone	800-932-4202
Email	orders@fci-ophthalmics.com
Phone	800-932-4202
Email	orders@fci-ophthalmics.com
Phone	800-932-4202
Email	orders@fci-ophthalmics.com
Phone	800-932-4202
Email	orders@fci-ophthalmics.com
Phone	800-932-4202
Email	orders@fci-ophthalmics.com
Phone	800-932-4202
Email	orders@fci-ophthalmics.com
Phone	800-932-4202
Email	orders@fci-ophthalmics.com
Phone	800-932-4202
Email	orders@fci-ophthalmics.com
Phone	800-932-4202
Email	orders@fci-ophthalmics.com
Phone	800-932-4202
Email	orders@fci-ophthalmics.com
Phone	800-932-4202
Email	orders@fci-ophthalmics.com
Phone	800-932-4202
Email	orders@fci-ophthalmics.com
Phone	800-932-4202
Email	orders@fci-ophthalmics.com

Device Dimensions

Height	1.25 Millimeter
Length	100 Millimeter
Width	4 Millimeter
Height	1.25 Millimeter
Length	100 Millimeter
Width	4 Millimeter
Height	1.25 Millimeter
Length	100 Millimeter
Width	4 Millimeter
Height	1.25 Millimeter
Length	100 Millimeter
Width	4 Millimeter
Height	1.25 Millimeter
Length	100 Millimeter
Width	4 Millimeter
Height	1.25 Millimeter
Length	100 Millimeter
Width	4 Millimeter
Height	1.25 Millimeter
Length	100 Millimeter
Width	4 Millimeter
Height	1.25 Millimeter
Length	100 Millimeter
Width	4 Millimeter
Height	1.25 Millimeter
Length	100 Millimeter
Width	4 Millimeter
Height	1.25 Millimeter
Length	100 Millimeter
Width	4 Millimeter
Height	1.25 Millimeter
Length	100 Millimeter
Width	4 Millimeter
Height	1.25 Millimeter
Length	100 Millimeter
Width	4 Millimeter
Height	1.25 Millimeter
Length	100 Millimeter
Width	4 Millimeter
Height	1.25 Millimeter
Length	100 Millimeter
Width	4 Millimeter
Height	1.25 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760087121193 [Primary]
GS1	53760087121198 [Unit of Use]

FDA Product Code

HQX	Implant, Orbital, Extra-Ocular

Sterilization

Steralize Prior To Use	true
Device Is Sterile	true

[53760087121198]

Radiation Sterilization

[53760087121198]

Radiation Sterilization

[53760087121198]

Radiation Sterilization

[53760087121198]

Radiation Sterilization

[53760087121198]

Radiation Sterilization

[53760087121198]

Radiation Sterilization

[53760087121198]

Radiation Sterilization

[53760087121198]

Radiation Sterilization

[53760087121198]

Radiation Sterilization

[53760087121198]

Radiation Sterilization

[53760087121198]

Radiation Sterilization

[53760087121198]

Radiation Sterilization

[53760087121198]

Radiation Sterilization

[53760087121198]

Radiation Sterilization

[53760087121198]

Radiation Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-03-16
Device Publish Date	2020-03-06

On-Brand Devices [Scleral buckling device, non-bioabsorbable]

03760087121162	A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buc
53760087127350	A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buc
03760087122114	A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buc
53760087122058	A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buc
53760087121471	A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buc
53760087121327	A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buc
53760087121983	A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buc
03760087122428	A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buc
03760087122152	A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buc
03760087122145	A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buc
03760087122138	A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buc
03760087122121	A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buc
03760087122091	A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buc
03760087122084	A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buc
03760087122077	A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buc
53760087122065	A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buc
53760087122003	A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buc
53760087121952	A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buc
53760087121907	A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buc
53760087121891	A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buc
53760087121877	A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buc
53760087121822	A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buc
53760087121815	A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buc
53760087121808	A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buc
03760087121674	A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buc
03760087121650	A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buc
53760087121556	A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buc
53760087121549	A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buc
53760087121532	A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buc
53760087121525	A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buc
53760087121457	A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buc
53760087121433	A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buc
53760087121426	A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buc
53760087121396	A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buc
53760087121303	A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buc
53760087121297	A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buc
53760087121259	A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buc
53760087121242	A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buc
53760087121235	A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buc
53760087121211	A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buc
53760087121198	A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buc
53760087121181	A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buc
53760087121174	A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buc