| Primary Device ID | B564MVLV40HR2 |
| NIH Device Record Key | ed280c99-8415-4790-aa17-d7f164126b5f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PHAKOS |
| Version Model Number | MV LV 40 HR |
| Catalog Number | MV LV 40 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 | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B564MVLV40HR0 [Primary] |
| HIBCC | B564MVLV40HR2 [Package] Contains: B564MVLV40HR0 Package: [5 Units] In Commercial Distribution |
| HJK | Lens, Contact, Polymethylmethacrylate, Diagnostic |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[B564MVLV40HR2]
Ethylene Oxide
[B564MVLV40HR2]
Ethylene Oxide
[B564MVLV40HR2]
Ethylene Oxide
[B564MVLV40HR2]
Ethylene Oxide
[B564MVLV40HR2]
Ethylene Oxide
[B564MVLV40HR2]
Ethylene Oxide
[B564MVLV40HR2]
Ethylene Oxide
[B564MVLV40HR2]
Ethylene Oxide
[B564MVLV40HR2]
Ethylene Oxide
[B564MVLV40HR2]
Ethylene Oxide
[B564MVLV40HR2]
Ethylene Oxide
[B564MVLV40HR2]
Ethylene Oxide
[B564MVLV40HR2]
Ethylene Oxide
[B564MVLV40HR2]
Ethylene Oxide
[B564MVLV40HR2]
Ethylene Oxide
[B564MVLV40HR2]
Ethylene Oxide
[B564MVLV40HR2]
Ethylene Oxide
[B564MVLV40HR2]
Ethylene Oxide
[B564MVLV40HR2]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-02-18 |
| Device Publish Date | 2019-01-16 |
| 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 |