Primary Device ID | 17290117772420 |
NIH Device Record Key | 30c6624b-fa96-43bc-82bd-34e8e77b5b2e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | OPT™ Shields |
Version Model Number | NA |
Company DUNS | 600763501 |
Company Name | LUMENIS BE LTD |
Device Count | 12 |
DM Exempt | false |
Pre-market Exempt | true |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07290117772423 [Unit of Use] |
GS1 | 17290117772420 [Primary] |
HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-01-03 |
Device Publish Date | 2023-12-26 |
07290117772447 - FoLiCool™ Tip | 2024-03-25 |
07290117772522 - FoLix™ | 2024-03-25 |
07290117772539 - FoLix™ Handpiece | 2024-03-25 |
07290117772393 - LUSTER System | 2024-01-30 |
07290117772409 - LUSTER Handpiece | 2024-01-30 |
07290117772416 - LUSTER Tip, Round | 2024-01-30 |
17290117772420 - OPT™ Shields | 2024-01-03 |
17290117772420 - OPT™ Shields | 2024-01-03 |
07290117771372 - AcuPulse | 2023-12-12 |