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

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
04049471100167 - Treatment Pack (Type KP)2024-02-19 single use accessory for ZEISS femtosecond lasers
04049471100136 - Treatment Pack (Size S)2024-02-16 single use accessory for ZEISS femtosecond lasers
04049539101341 - EyeMag Smart2023-11-16
04049539101358 - EyeMag Pro S2023-11-16
04049539101365 - EyeMag Pro F2023-11-16
04049539064103 - PENTERO® 800 S 2023-09-19

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