FDA.reportPublic FDA data

HALF-SPONGE 2.75 X 7.5 TYPE 511

Primary DI
33760087121972
Brand
HALF-SPONGE 2.75 X 7.5 TYPE 511
Company
FCI S A S FCI 20 22
Model
S5.6475
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.
Published
2021-05-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HQXImplant, Orbital, Extra-Ocular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQXImplant, Orbital, Extra-OcularOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
33760087121972PackageGS13In Commercial Distribution
03760087121971PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3376008712197233760087121972
03760087121971037600871219713760087121971

GMDN Terms#

Term, Definition table
TermDefinition
Scleral buckling device, non-bioabsorbableA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
763408366
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
13700773729651STOPLOSS® JONES TUBE 3,5 X 9 MM S1.73092026-04-20
13700773729668STOPLOSS® JONES TUBE 3,5 X 10 MM S1.73102026-04-20
13700773729675STOPLOSS® JONES TUBE 3,5 X 11 MM S1.73112026-04-20
13700773729682STOPLOSS® JONES TUBE 3,5 X 12 MM S1.73122026-04-20
13700773729699STOPLOSS® JONES TUBE 3,5 X 13 MM S1.73132026-04-20
13700773730817STOPLOSS® JONES TUBE INTRODUCER SET S1.75002026-04-20
13700773731920STOPLOSS® JONES TUBE 3,5 X 14 MM S1.73142026-04-20
13700773731937STOPLOSS® JONES TUBE 3,5 X 15 MM S1.73152026-04-20
13700773731968STOPLOSS® JONES TUBE 3,5 X 16 MM S1.73162026-04-20
13700773731975STOPLOSS® JONES TUBE 3,5 X 17 MM S1.73172026-04-20
13700773731982STOPLOSS® JONES TUBE 3,5 X 18 MM S1.73182026-04-20
13700773731999STOPLOSS® JONES TUBE 3,5 X 19 MM S1.73192026-04-20
13700773732002STOPLOSS® JONES TUBE 3,5 X 20 MM S1.73202026-04-20
13700773732019STOPLOSS® JONES TUBE 3,5 X 21 MM S1.73212026-04-20
13700773732026STOPLOSS® JONES TUBE 3,5 X 22 MM S1.73222026-04-20
13700773732033STOPLOSS® JONES TUBE 4 X 9 MM S1.74092026-04-20
13700773732040STOPLOSS® JONES TUBE 4 X 10 MM S1.74102026-04-20
13700773732057STOPLOSS® JONES TUBE 4 X 11 MM S1.74112026-04-20
13700773732064STOPLOSS® JONES TUBE 4 X 12 MM S1.74122026-04-20
13700773732071STOPLOSS® JONES TUBE 4 X 13 MM S1.74132026-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760087121971HALF-SPONGE 2.75 X 7.5 TYPE 511FCI S A S FCI 20 22HQX2021-05-30
08717872014487Scleral Buckling Product Style 106, Meridional Implant - 10.5mmD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQX2020-11-16
08717872014555Scleral Buckling Product Style 505T, 5.0mm Round Tunel SpongeD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQX2020-11-16
08717872014661Scleral Buckling Product Style 519G, 3.2mm x 7.5mm Grooved SpongeD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQX2020-11-16
18717872014484Scleral Buckling Product Style 106, Meridional Implant - 10.5mmD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQX2020-11-16
18717872014552Scleral Buckling Product Style 505T, 5.0mm Round Tunel SpongeD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQX2020-11-16
18717872014668Scleral Buckling Product Style 519G, 3.2mm x 7.5mm Grooved SpongeD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQX2020-11-16
03760087121179Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121186Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121193Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121216Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121230Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121247Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121254Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121292Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121308Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121391Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121421Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121438Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121452Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121520Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121537Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121544Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121551Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121803Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121810Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121827Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121872Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121896Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06
03760087121902Scleral buckling device, non-bioabsorbableFCI S A S FCI 20 22HQX2020-03-06