OPT™ Shields

GUDID 17290117772420

LUMENIS BE LTD

Radiation/mechanical corneal shield, single-use
Primary Device ID17290117772420
NIH Device Record Key30c6624b-fa96-43bc-82bd-34e8e77b5b2e
Commercial Distribution StatusIn Commercial Distribution
Brand NameOPT™ Shields
Version Model NumberNA
Company DUNS600763501
Company NameLUMENIS BE LTD
Device Count12
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290117772423 [Unit of Use]
GS117290117772420 [Primary]

FDA Product Code

HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-03
Device Publish Date2023-12-26

Devices Manufactured by LUMENIS BE LTD

07290117772447 - FoLiCool™ Tip2024-03-25
07290117772522 - FoLix™2024-03-25
07290117772539 - FoLix™ Handpiece2024-03-25
07290117772393 - LUSTER System2024-01-30
07290117772409 - LUSTER Handpiece2024-01-30
07290117772416 - LUSTER Tip, Round2024-01-30
17290117772420 - OPT™ Shields2024-01-03
17290117772420 - OPT™ Shields2024-01-03
07290117771372 - AcuPulse2023-12-12

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