FDA.reportPublic FDA data

MIRA Cryosurgical Probe, Gaynon Curved Cataract

Primary DI
10850510007573
Brand
MIRA Cryosurgical Probe, Gaynon Curved Cataract
Company
MIRA, INC.
Model
CR4085
Catalog number
CR4085
Device description
2mm Gaynon ROP Probe
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEHUnit, Cryosurgical, Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEHUnit, Cryosurgical, AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K760686000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K760686000CRYOLYZER ALPHA (CRYOSURG.EQUIP.)Cryo-Labs, Inc.1976-11-01GEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850510007573PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085051000757310850510007573

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic cryosurgical system, mechanicalAn assembly of mechanical devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to a target tissue for its destruction and removal during an ophthalmic surgical procedure. The system typically includes a mechanical regulator to control the flow of cryogen contained in an attached cylinder, and dedicated cryogen-cooled hand-held applicators (probes) to apply the cold to the tissue. The device is typically used to remove cataracts by the formation of an adherent ice ball in the lens, to freeze the eye and adjunct parts for surgical removal of scars, and to freeze tumours.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
5082787877customerservice@mirainc.us

Regulatory Flags#

DUNS number
001414358
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
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
00884450457511C2 CryoBalloon™Merit Medical Systems, Inc.GEH2026-06-02
00884450457528C2 CryoBalloon™Merit Medical Systems, Inc.GEH2026-06-02
00884450457566C2 CryoBalloon™Merit Medical Systems, Inc.GEH2026-06-02
00884450457573C2 CryoBalloon™Merit Medical Systems, Inc.GEH2026-06-02
10840143902666cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902673cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902680cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902697cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902703cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902710cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902727cryoICE® SystemATRICURE, INC.GEH2026-05-27
10840143902734cryoICE® SystemATRICURE, INC.GEH2026-05-27
30840143904343cryoICE® SystemATRICURE, INC.GEH2026-05-27
30840143912164AtriCure® cryoICE® BOXATRICURE, INC.GEH2026-05-27
04050147024694ErbeErbe Elektromedizin GmbHGEH2026-05-26
08800073100148TargetCool-eRecensMedical, Inc.GEH2026-05-14
06974083413115CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413122CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413313CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413320CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413337CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413412CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413528CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-23
06974083413221CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-22
06974083410718CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-01
06974083413214CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-01
06974083413511CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-01
06974083413818CryoThinMedinux (Tianjin) Technologies Co., Ltd.GEH2026-04-01
00860009734814ArtemisEigen Health Services LLCGEH2026-01-28
00860009734821Artemis-TPOSEigen Health Services LLCGEH2026-01-28