Retina Workplace

GUDID 04049471070118

This database entry covers UDI for SW Versions 1.0 and higher: (01)04049471070118(10)200 -> Version 2.0; (01)04049471070118(10)201-> Version 2.0.1; (01)04049471070118(10)251-> Version 2.5.1; (01)04049471070118(10)260-> Version 2.6

Carl Zeiss Meditec AG

Patient health record information system application software
Primary Device ID04049471070118
NIH Device Record Keye46670db-c0aa-445b-b05d-7f630abb0ab1
Commercial Distribution StatusIn Commercial Distribution
Brand NameRetina Workplace
Version Model Number1.0
Company DUNS314594680
Company NameCarl Zeiss Meditec AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104049471070118 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NFJSystem, Image Management, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2016-09-16

Devices Manufactured by Carl Zeiss Meditec AG

04049539106704 - Single-use lenses for RESIGHT, MACULA LENS2024-11-15 Single- use lenses for RESIGHT are ophthalmic surgical microscope lenses used in combination with the ZEISS RESIGHT fundus viewi
04049539106735 - Single-use lenses for RESIGHT, WIDE-ANGLE LENS2024-11-15 Single- use lenses for RESIGHT are ophthalmic surgical microscope lenses used in combination with the ZEISS RESIGHT fundus viewi
04049539106766 - Single-use lenses for RESIGHT, ULTRA WIDE-ANGLE LENS2024-11-15 Single- use lenses for RESIGHT are ophthalmic surgical microscope lenses used in combination with the ZEISS RESIGHT fundus viewi
04049539069214 - CALLISTO eye Panel PC2024-06-14
04049539070302 - CALLISTO eye Software2024-06-14
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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