Scleral buckling device, non-bioabsorbable S5.4821U

GUDID 03760087122428

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

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Primary Device ID03760087122428
NIH Device Record Key7a04d030-903b-42df-b88e-b5c4827f97b9
Commercial Distribution StatusIn Commercial Distribution
Brand NameScleral buckling device, non-bioabsorbable
Version Model NumberePTFE BAND 2.1 X 5.5 mm
Catalog NumberS5.4821U
Company DUNS763408366
Company NameFCI S A S FCI 20 22
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-932-4202
Emailorders@fci-ophthalmics.com
Phone800-932-4202
Emailorders@fci-ophthalmics.com
Phone800-932-4202
Emailorders@fci-ophthalmics.com
Phone800-932-4202
Emailorders@fci-ophthalmics.com
Phone800-932-4202
Emailorders@fci-ophthalmics.com
Phone800-932-4202
Emailorders@fci-ophthalmics.com
Phone800-932-4202
Emailorders@fci-ophthalmics.com
Phone800-932-4202
Emailorders@fci-ophthalmics.com
Phone800-932-4202
Emailorders@fci-ophthalmics.com
Phone800-932-4202
Emailorders@fci-ophthalmics.com
Phone800-932-4202
Emailorders@fci-ophthalmics.com
Phone800-932-4202
Emailorders@fci-ophthalmics.com
Phone800-932-4202
Emailorders@fci-ophthalmics.com
Phone800-932-4202
Emailorders@fci-ophthalmics.com
Phone800-932-4202
Emailorders@fci-ophthalmics.com

Device Dimensions

Height2.1 Millimeter
Length120 Millimeter
Width5.5 Millimeter
Height2.1 Millimeter
Length120 Millimeter
Width5.5 Millimeter
Height2.1 Millimeter
Length120 Millimeter
Width5.5 Millimeter
Height2.1 Millimeter
Length120 Millimeter
Width5.5 Millimeter
Height2.1 Millimeter
Length120 Millimeter
Width5.5 Millimeter
Height2.1 Millimeter
Length120 Millimeter
Width5.5 Millimeter
Height2.1 Millimeter
Length120 Millimeter
Width5.5 Millimeter
Height2.1 Millimeter
Length120 Millimeter
Width5.5 Millimeter
Height2.1 Millimeter
Length120 Millimeter
Width5.5 Millimeter
Height2.1 Millimeter
Length120 Millimeter
Width5.5 Millimeter
Height2.1 Millimeter
Length120 Millimeter
Width5.5 Millimeter
Height2.1 Millimeter
Length120 Millimeter
Width5.5 Millimeter
Height2.1 Millimeter
Length120 Millimeter
Width5.5 Millimeter
Height2.1 Millimeter
Length120 Millimeter
Width5.5 Millimeter
Height2.1 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS103760087122428 [Primary]

FDA Product Code

HQXImplant, Orbital, Extra-Ocular

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[03760087122428]

Ethylene Oxide

[03760087122428]

Ethylene Oxide

[03760087122428]

Ethylene Oxide

[03760087122428]

Ethylene Oxide

[03760087122428]

Ethylene Oxide

[03760087122428]

Ethylene Oxide

[03760087122428]

Ethylene Oxide

[03760087122428]

Ethylene Oxide

[03760087122428]

Ethylene Oxide

[03760087122428]

Ethylene Oxide

[03760087122428]

Ethylene Oxide

[03760087122428]

Ethylene Oxide

[03760087122428]

Ethylene Oxide

[03760087122428]

Ethylene Oxide

[03760087122428]

Ethylene Oxide

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-16
Device Publish Date2020-03-06

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

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