FDA.reportPublic FDA data

NA

Primary DI
10818255011231
Brand
NA
Company
MICROVISION, INC.
Model
Style 507
Catalog number
5408
Device description
Oval Silicone Sponge 5.5mm x 7.5mm x 80mm
Published
2017-12-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K023481000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023481000MICROVISION SCLERAL BUCKLING COMPONENTSMicrovision, Inc.2003-01-08HQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30818255011235PackageGS15In Commercial Distribution
10818255011231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3081825501123530818255011235
1081825501123110818255011231

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height5.5Millimeter
Length80Millimeter
Width7.5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry

Regulatory Flags#

DUNS number
013486803
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10818255011194NAStyle 50354032017-12-22
10818255011200NAStyle 50454042017-12-22
10818255011217NAStyle 50554052017-12-22
10818255011224NAStyle 50654072017-12-22
10818255011323NAStyle 27754312017-12-22
10818255011330NAStyle 27954322017-12-22
10818255011378NAStyle 27654382017-12-22
10818255011385NAStyle 28654402017-12-22
10818255011392NAStyle 28754412017-12-22
10818255011415NAStyle 24054452017-12-22
10818255011422NAStyle 27054462017-12-22
10818255011439NAStyle 7054472017-12-22
10818255011446NAStyle 4854482017-12-22
10818255011453NAStyle 4054492017-12-22
10818255011460NAStyle 4254502017-12-22
10818255011491NAStyle 10654542017-12-22
10818255011521NAStyle 11254602017-12-22
30818255011198NAStyle 50354032017-12-22
30818255011204NAStyle 50454042017-12-22
30818255011211NAStyle 50554052017-12-22

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
33760087121972HALF-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