TOMOCAP 18829

GUDID 04059237000747

Heidelberg Engineering GmbH

Eye anterior segment analyser
Primary Device ID04059237000747
NIH Device Record Key631fa9f1-75fa-4c36-9bba-b2b6f54f2e1f
Commercial Distribution StatusIn Commercial Distribution
Brand NameTOMOCAP
Version Model NumberN/A
Catalog Number18829
Company DUNS329833875
Company NameHeidelberg Engineering GmbH
Device Count1
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
GS104059237000747 [Primary]
GS104059237000860 [Unit of Use]

FDA Product Code

MXKDevice, Analysis, Anterior Segment

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-06
Device Publish Date2020-10-29

Devices Manufactured by Heidelberg Engineering GmbH

04059237000723 - SPECTRALIS2024-10-14
04059237000792 - SPECTRALIS2024-10-14
04059237001027 - SPECTRALIS2024-10-14
04059237001034 - SPECTRALIS2024-10-14
04059237000938 - ANTERION2023-11-27
04059237000945 - ANTERION2023-11-27
04059237000730 - HRT32023-03-13
04059237000884 - SPECTRALIS2022-11-03

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