Treatment Pack (Size L)

GUDID 04049471110067

single use patient interface for VisuMax laser keratome

Carl Zeiss Meditec AG

Femtosecond ophthalmic solid-state laser system
Primary Device ID04049471110067
NIH Device Record Key1230a7b5-d0c1-4574-af43-e5d0dd4b7290
Commercial Distribution StatusIn Commercial Distribution
Brand NameTreatment Pack (Size L)
Version Model Number1462-334
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
GS104049471100068 [Unit of Use]
GS104049471110067 [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 Number3
Public Version Date2018-11-23
Device Publish Date2016-09-23

On-Brand Devices [Treatment Pack (Size L) ]

04049471110067single use patient interface for VisuMax laser keratome
04049471100150single use accessory for ZEISS femtosecond lasers

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