MIRA Cryosurgical Console CR4000

GUDID 10850510007467

Ophthalmic Cryo Unit

MIRA, INC.

Ophthalmic cryosurgical system, mechanical Ophthalmic cryosurgical system, mechanical Ophthalmic cryosurgical system, mechanical Ophthalmic cryosurgical system, mechanical Ophthalmic cryosurgical system, mechanical Ophthalmic cryosurgical system, mechanical Ophthalmic cryosurgical system, mechanical Ophthalmic cryosurgical system, mechanical Ophthalmic cryosurgical system, mechanical Ophthalmic cryosurgical system, mechanical Ophthalmic cryosurgical system, mechanical Ophthalmic cryosurgical system, mechanical Ophthalmic cryosurgical system, mechanical Ophthalmic cryosurgical system, mechanical Ophthalmic cryosurgical system, mechanical

• Primary Device ID: 10850510007467
• NIH Device Record Key: 0f13c041-978f-4309-87b6-670917910cb3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MIRA Cryosurgical Console
• Version Model Number: CR4000
• Catalog Number: CR4000
• Company DUNS: 001414358
• Company Name: MIRA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 5082787877
• Email: customerservice@mirainc.us
• Phone: 5082787877
• Email: customerservice@mirainc.us
• Phone: 5082787877
• Email: customerservice@mirainc.us
• Phone: 5082787877
• Email: customerservice@mirainc.us
• Phone: 5082787877
• Email: customerservice@mirainc.us
• Phone: 5082787877
• Email: customerservice@mirainc.us
• Phone: 5082787877
• Email: customerservice@mirainc.us
• Phone: 5082787877
• Email: customerservice@mirainc.us
• Phone: 5082787877
• Email: customerservice@mirainc.us
• Phone: 5082787877
• Email: customerservice@mirainc.us
• Phone: 5082787877
• Email: customerservice@mirainc.us
• Phone: 5082787877
• Email: customerservice@mirainc.us
• Phone: 5082787877
• Email: customerservice@mirainc.us
• Phone: 5082787877
• Email: customerservice@mirainc.us
• Phone: 5082787877
• Email: customerservice@mirainc.us

Device Identifiers

Device Issuing Agency	Device ID
GS1	10850510007467 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K760686

FDA Product Code

• GEH: Unit, Cryosurgical, Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-12-13
• Device Publish Date: 2016-09-24

Devices Manufactured by MIRA, INC.

• 10850510007467 - MIRA Cryosurgical Console: 2022-12-13Ophthalmic Cryo Unit
• 10850510007467 - MIRA Cryosurgical Console: 2022-12-13 Ophthalmic Cryo Unit
• 10850510007474 - MIRA Cryosurgical Probe, Curved Retinal: 2022-12-13 2.8mm Curved Retinal Probe
• 10850510007481 - MIRA Cryosurgical Probe, Straight Retinal: 2022-12-13 2.8mm Straight Retinal Probe
• 10850510007498 - MIRA Cryosurgical Probe, Straight Cataract: 2022-12-13 2mm Straight Cataract Probe
• 10850510007504 - MIRA Cryosurgical Probe, Curved Cataract: 2022-12-13 2mm Curved Cataract Probe
• 10850510007511 - MIRA Cryosurgical Probe, Mini Curved Cataract: 2022-12-13 1.5mm Mini Curved Cataract Probe
• 10850510007528 - MIRA Cryosurgical Probe, Curved Glaucoma: 2022-12-13 3.5mm Curved Glaucoma Probe
• 10850510007535 - MIRA Cryosurgical Probe, Straight Vitreous: 2022-12-13 1.5mm Straight Vitreous Probe