MIRA Cryosurgical Console CR4000

GUDID 10850510007467

Ophthalmic Cryo Unit

MIRA, INC.

Ophthalmic cryosurgical system, mechanical
Primary Device ID10850510007467
NIH Device Record Key0f13c041-978f-4309-87b6-670917910cb3
Commercial Distribution StatusIn Commercial Distribution
Brand NameMIRA Cryosurgical Console
Version Model NumberCR4000
Catalog NumberCR4000
Company DUNS001414358
Company NameMIRA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone5082787877
Emailcustomerservice@mirainc.us
Phone5082787877
Emailcustomerservice@mirainc.us
Phone5082787877
Emailcustomerservice@mirainc.us
Phone5082787877
Emailcustomerservice@mirainc.us
Phone5082787877
Emailcustomerservice@mirainc.us
Phone5082787877
Emailcustomerservice@mirainc.us
Phone5082787877
Emailcustomerservice@mirainc.us
Phone5082787877
Emailcustomerservice@mirainc.us
Phone5082787877
Emailcustomerservice@mirainc.us
Phone5082787877
Emailcustomerservice@mirainc.us
Phone5082787877
Emailcustomerservice@mirainc.us
Phone5082787877
Emailcustomerservice@mirainc.us
Phone5082787877
Emailcustomerservice@mirainc.us
Phone5082787877
Emailcustomerservice@mirainc.us
Phone5082787877
Emailcustomerservice@mirainc.us

Device Identifiers

Device Issuing AgencyDevice ID
GS110850510007467 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEHUnit, Cryosurgical, Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-12-13
Device Publish Date2016-09-24

Devices Manufactured by MIRA, INC.

10850510007467 - MIRA Cryosurgical Console2022-12-13Ophthalmic Cryo Unit
10850510007467 - MIRA Cryosurgical Console2022-12-13 Ophthalmic Cryo Unit
10850510007474 - MIRA Cryosurgical Probe, Curved Retinal2022-12-13 2.8mm Curved Retinal Probe
10850510007481 - MIRA Cryosurgical Probe, Straight Retinal2022-12-13 2.8mm Straight Retinal Probe
10850510007498 - MIRA Cryosurgical Probe, Straight Cataract2022-12-13 2mm Straight Cataract Probe
10850510007504 - MIRA Cryosurgical Probe, Curved Cataract2022-12-13 2mm Curved Cataract Probe
10850510007511 - MIRA Cryosurgical Probe, Mini Curved Cataract2022-12-13 1.5mm Mini Curved Cataract Probe
10850510007528 - MIRA Cryosurgical Probe, Curved Glaucoma2022-12-13 3.5mm Curved Glaucoma Probe
10850510007535 - MIRA Cryosurgical Probe, Straight Vitreous2022-12-13 1.5mm Straight Vitreous Probe

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