PHAKOS MV LV 48 HR

GUDID B564MVLV48HR2

HR PANORAMIC wide angle lens, with ring and removable handle

PHAKOS

Vitrectomy contact lens, single-use

• Primary Device ID: B564MVLV48HR2
• NIH Device Record Key: db34c03c-1484-4708-8fd1-afebbc9850f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PHAKOS
• Version Model Number: MV LV 48 HR
• Catalog Number: MV LV 48 HR
• Company DUNS: 401106299
• Company Name: PHAKOS
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B564MVLV48HR0 [Primary]
HIBCC	B564MVLV48HR2 [Package]; Contains: B564MVLV48HR0; Package: box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173944

FDA Product Code

• HJK: Lens, Contact, Polymethylmethacrylate, Diagnostic

Sterilization

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

[B564MVLV48HR2]

Ethylene Oxide

[B564MVLV48HR2]

Ethylene Oxide

[B564MVLV48HR2]

Ethylene Oxide

[B564MVLV48HR2]

Ethylene Oxide

[B564MVLV48HR2]

Ethylene Oxide

[B564MVLV48HR2]

Ethylene Oxide

[B564MVLV48HR2]

Ethylene Oxide

[B564MVLV48HR2]

Ethylene Oxide

[B564MVLV48HR2]

Ethylene Oxide

[B564MVLV48HR2]

Ethylene Oxide

[B564MVLV48HR2]

Ethylene Oxide

[B564MVLV48HR2]

Ethylene Oxide

[B564MVLV48HR2]

Ethylene Oxide

[B564MVLV48HR2]

Ethylene Oxide

[B564MVLV48HR2]

Ethylene Oxide

[B564MVLV48HR2]

Ethylene Oxide

[B564MVLV48HR2]

Ethylene Oxide

[B564MVLV48HR2]

Ethylene Oxide

[B564MVLV48HR2]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-18
• Device Publish Date: 2019-01-16

On-Brand Devices [PHAKOS]

• B564MVLV562: Wide-field consultation lens
• B564MVLV552: Iridectomy Lens
• B564MVLV542: Capsulotomy Lens
• B564MVLV532: 3-prism laser lens
• B564MVLV522: 3-prism operating room lens
• B564MVLV512: 3-prism consultation lens
• B564MVLV502: Right/left gonioprism lens with removable handle
• B564MVLV492: SSV Flat lens
• B564MVLV48HR2: HR PANORAMIC wide angle lens, with ring and removable handle
• B564MVLV482: PANORAMIC wide angle lens, with ring and removable handle
• B564MVLV472: Right gonioprism lens with handle
• B564MVLV462: Left gonioprism lens with handle
• B564MVLV45HR2: HR 30° prismatic lens with Silicone ring
• B564MVLV452: 30° prismatic lens with Silicone ring
• B564MVLV43HR2: HR Magnifying lens with Silicone ring
• B564MVLV432: Magnifying lens with Silicone ring
• B564MVLV42HR2: HR Biconcave lens with Silicone ring
• B564MVLV422: Biconcave lens with Silicone ring
• B564MVLV41HR2: HR Wide angle lens Consultation
• B564MVLV412: Wide angle lens with Silicone ring
• B564MVLV40HR2: HR Flat lens with Silicone ring
• B564MVLV402: Flat lens with Silicone ring
• B564MVCY1000: Disposable Retinal Cryo Probe
• B564MVAS102: Single-use silicone ring
• B564MVAD99NG0: Adapter Keeler ACU/CTU used with PHAKOS Disposable Retinal Cryo Probe
• B564MVAD98NG0: Adapter Cryomaster I used with PHAKOS Disposable Retinal Cryo Probe
• B564MVAD97NG0: Adapter Erbe / Optikon used with PHAKOS Disposable Retinal Cryo Probe
• B564MVAD96NG0: Adapter Cryomaster II used with PHAKOS Disposable Retinal Cryo Probe
• B564MVAD95NG0: Adapter Dorc used with PHAKOS Disposable Retinal Cryo Probe
• B564MVAD94NG0: Adapter Dorc Cryostar for use with PHAKOS Disposable Retinal Cryo Probe
• B564MVAD930: Adapter Frigitronics used with PHAKOS Disposable Retinal Cryo Probe