FDA.reportPublic FDA data

MIRA Cryosurgical Probe, Lashkari Trichiasis

Primary DI
10850510007597
Brand
MIRA Cryosurgical Probe, Lashkari Trichiasis
Company
MIRA, INC.
Model
CR4095
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
HPSUnit, Cryophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HPSUnit, CryophthalmicOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K923629000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K923629000OPHTHALMIC TRICHIASIS PROBEMira, Inc.1992-10-19HPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850510007597PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085051000759710850510007597

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
88719214223454VitreQVitreq B.V.HPS2021-02-01
08719214223458VitreQVitreq B.V.HPS2021-02-01