VitreQ

GUDID 08719214223458

CryoTreQ

Vitreq B.V.

Ophthalmic cryosurgical system, mechanical

• Primary Device ID: 08719214223458
• NIH Device Record Key: b108f60c-92cc-4f97-8227-60e7f961c16b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VitreQ
• Version Model Number: CT00.D01
• Company DUNS: 491393613
• Company Name: Vitreq B.V.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1.866.906.8080
• Email: customersupport@bvimedical.com
• Phone: 1.866.906.8080
• Email: customersupport@bvimedical.com
• Phone: 1.866.906.8080
• Email: customersupport@bvimedical.com
• Phone: 1.866.906.8080
• Email: customersupport@bvimedical.com
• Phone: 1.866.906.8080
• Email: customersupport@bvimedical.com
• Phone: 1.866.906.8080
• Email: customersupport@bvimedical.com
• Phone: 1.866.906.8080
• Email: customersupport@bvimedical.com
• Phone: 1.866.906.8080
• Email: customersupport@bvimedical.com
• Phone: 1.866.906.8080
• Email: customersupport@bvimedical.com
• Phone: 1.866.906.8080
• Email: customersupport@bvimedical.com
• Phone: 1.866.906.8080
• Email: customersupport@bvimedical.com
• Phone: 1.866.906.8080
• Email: customersupport@bvimedical.com
• Phone: 1.866.906.8080
• Email: customersupport@bvimedical.com
• Phone: 1.866.906.8080
• Email: customersupport@bvimedical.com
• Phone: 1.866.906.8080
• Email: customersupport@bvimedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08719214223458 [Package]; Contains: 88719214223454; Package: Box [3 Units]; In Commercial Distribution
GS1	88719214223454 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202038

FDA Product Code

• HPS: Unit, Cryophthalmic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-09
• Device Publish Date: 2021-02-01

On-Brand Devices [VitreQ]

• 08719214221928: Williamson Scleral Depressor
• 08719214222611: 27G 90° Directional Laser Probes, Iridex® Style
• 08719214222598: 25G (90°) Directional Laser Probes, Alcon® Style
• 08719214222550: 25G (90°) Directional Illuminated Laser Probes, Iridex® Style
• 08719214222536: 25G (90°) Directional Illuminated Laser Probes, Alcon® Style
• 08719214222499: 25G 90° Directional Laser Probes, Iridex® Style
• 08719214222475: 25G 90° Directional Laser Probes, Alcon® Style
• 08719214222437: 23G (90°) Directional Illuminated Laser Probes, Iridex® Style
• 08719214222413: 23G (90°) Directional Illuminated Laser Probes, Alcon® Style
• 08719214222376: 23G 90° Directional Laser Probes, Iridex® Style
• 08719214222352: 23G 90° Directional Laser Probes, Alcon® Style
• 08719214222338: DORC® Light Source Adaptor
• 08719214222321: Ruck® Light Source Adaptor
• 08719214222314: Geuder® Light Source Adaptor
• 08719214222307: Stellaris® Light Source Adaptor
• 08719214222291: Constellation® Light Source Adaptor
• 08719214222277: 29G Spotlight, Directional Chandelier
• 08719214222253: 27G 45° Shielded Light Fibers
• 08719214222239: 27G Wide View Light Fibers
• 08719214222215: 27G Standard Light Fibers
• 08719214222192: 25G 45° Shielded Light Fibers
• 08719214222178: 25G Wide View Light Fibers
• 08719214222154: 25G Standard Light Fibers
• 08719214222130: 23G 45° Shielded Light Fibers
• 08719214222116: 23G Wide View Light Fibers
• 08719214222093: 23G Standard Light Fibers
• 08719214222079: 20G 45° Shielded Light Fibers
• 08719214222055: 20G Wide View Light Fibers
• 08719214222031: 20G Standard Light Fibers
• 08719214223458: CryoTreQ
• 88719214222617: 27G 90° Directional Laser Probes, Iridex® Style
• 88719214222594: 25G (90°) Directional Laser Probes, Alcon® Compatible
• 88719214222556: 25G (90°) Directional Illuminated Laser Probes, Iridex® Compatible
• 88719214222532: 25G (90°) Directional Illuminated Laser Probes, Alcon® Compatible
• 88719214222495: 25G 90° Directional Laser Probes, Iridex® Compatible
• 88719214222471: 25G 90° Directional Laser Probes, Alcon® Compatible
• 88719214222433: 23G (90°) Directional Illuminated Laser Probes, Iridex® Compatible
• 88719214222419: 23G (90°) Directional Illuminated Laser Probes, Alcon® Compatible
• 88719214222372: 23G 90° Directional Laser Probes, Iridex® Compatible
• 88719214222358: 23G 90° Directional Laser Probes, Alcon® Compatible
• 88719214222273: 29G Spotlight, Directional Chandelier
• 88719214222259: 27G 45° Shielded Light Fibers
• 88719214222235: 27G Wide View Light Fibers
• 88719214222211: 27G Standard Light Fibers
• 88719214222198: 25G 45° Shielded Light Fibers
• 88719214222174: 25G Wide View Light Fibers
• 88719214222150: 25G Standard Light Fibers
• 88719214222136: 23G 45° Shielded Light Fibers
• 88719214222112: 23G Wide View Light Fibers
• 88719214222099: 23G Standard Light Fibers