MIRA Gragoudas Ring

GUDID 20850510007457

Scleral Marker For Proton Beam Irradiation

MIRA, INC.

Proton therapy system beam-delivery system

• Primary Device ID: 20850510007457
• NIH Device Record Key: fcbbc05a-7b9f-4edb-9939-1c4d68ba9dca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MIRA Gragoudas Ring
• Version Model Number: 175
• Company DUNS: 001414358
• Company Name: MIRA, INC.
• Device Count: 20
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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.net
• Phone: 5082787877
• Email: customerservice@mirainc.net
• 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	10850510007450 [Unit of Use]
GS1	20850510007457 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K760550

FDA Product Code

• HQX: Implant, Orbital, Extra-Ocular

Sterilization

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

[20850510007457]

Moist Heat or Steam Sterilization

[20850510007457]

Moist Heat or Steam Sterilization

[20850510007457]

Moist Heat or Steam Sterilization

[20850510007457]

Moist Heat or Steam Sterilization

[20850510007457]

Moist Heat or Steam Sterilization

[20850510007457]

Moist Heat or Steam Sterilization

[20850510007457]

Moist Heat or Steam Sterilization

[20850510007457]

Moist Heat or Steam Sterilization

[20850510007457]

Moist Heat or Steam Sterilization

[20850510007457]

Moist Heat or Steam Sterilization

[20850510007457]

Moist Heat or Steam Sterilization

[20850510007457]

Moist Heat or Steam Sterilization

[20850510007457]

Moist Heat or Steam Sterilization

[20850510007457]

Moist Heat or Steam Sterilization

[20850510007457]

Moist Heat or Steam Sterilization

[20850510007457]

Moist Heat or Steam Sterilization

[20850510007457]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

Devices Manufactured by MIRA, INC.

• 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