Treatment Packs (Size M)

GUDID 04049471110050

single use patient interface for VisuMax laser keratome

Carl Zeiss Meditec AG

Femtosecond ophthalmic solid-state laser system
Primary Device ID04049471110050
NIH Device Record Key021ac7d9-d8e1-4e0d-bfe6-229f7c0c5a1f
Commercial Distribution StatusIn Commercial Distribution
Brand NameTreatment Packs (Size M)
Version Model Number1462-333
Company DUNS314594680
Company NameCarl Zeiss Meditec AG
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

Weight400 Gram
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS104049471100051 [Unit of Use]
GS104049471110050 [Primary]

FDA Product Code

HQFLaser, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-23
Device Publish Date2016-09-23

Devices Manufactured by Carl Zeiss Meditec AG

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04049539066497 - ARTEVO 750/8502024-05-22 ARTEVO 750/850 is a surgical microscope intended for the magnification of the surgical area and for the visualization in surgica
04049471100143 - Treatment Pack (Size M)2024-02-19 single use accessory for ZEISS femtosecond lasers
04049471100150 - Treatment Pack (Size L)2024-02-19 single use accessory for ZEISS femtosecond lasers

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