FDA.reportPublic FDA data

MIRA IMEX Scleral Buckling Component

Primary DI
10850510007412
Brand
MIRA IMEX Scleral Buckling Component
Company
MIRA, INC.
Model
511
Catalog number
511
Device description
Half Oval 7.2mm
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

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
K950806000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K950806000SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTSMira, Inc.1996-06-05HQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20850510007419PackageGS15In Commercial Distribution
10850510007412PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2085051000741920850510007419
1085051000741210850510007412

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00room temperature
Storage Environment Humidity0 Percent (%) Relative Humidity70 Percent (%) Relative Humidity

Contacts#

Phone, Email table
PhoneEmail
5082787877customerservice@mirainc.us

Regulatory Flags#

DUNS number
001414358
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850510007016MIRA IMEX Scleral Buckling Component20202016-09-24
10850510007030MIRA IMEX Scleral Buckling Component40402016-09-24
10850510007047MIRA IMEX Scleral Buckling Component41412016-09-24
10850510007054MIRA IMEX Scleral Buckling Component42422016-09-24
10850510007061MIRA IMEX Scleral Buckling Component50502016-09-24
10850510007092MIRA IMEX Scleral Buckling Component75R75R2016-09-24
10850510007108MIRA IMEX Scleral Buckling Component1061062016-09-24
10850510007115MIRA IMEX Scleral Buckling Component2192192016-09-24
10850510007139MIRA IMEX Scleral Buckling Component2252252016-09-24
10850510007146MIRA IMEX Scleral Buckling Component2402402016-09-24
10850510007153MIRA IMEX Scleral Buckling Component2502502016-09-24
10850510007160MIRA IMEX Scleral Buckling Component2702702016-09-24
10850510007177MIRA IMEX Scleral Buckling Component2762762016-09-24
10850510007184MIRA IMEX Scleral Buckling Component2772772016-09-24
10850510007191MIRA IMEX Scleral Buckling Component2782782016-09-24
10850510007207MIRA IMEX Scleral Buckling Component2792792016-09-24
10850510007214MIRA IMEX Scleral Buckling Component2862862016-09-24
10850510007221MIRA IMEX Scleral Buckling Component2872872016-09-24
10850510007238MIRA IMEX Scleral Buckling Component5015012016-09-24
10850510007245MIRA IMEX Scleral Buckling Component5025022016-09-24

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