SPECTRALIS, HRT3, HEP

GUDID 04059237000242

Heidelberg Engineering GmbH

Spectral-domain optical coherence tomography system
Primary Device ID04059237000242
NIH Device Record Keydff9d58c-fe00-4267-b141-e8e25c17aaf3
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPECTRALIS, HRT3, HEP
Version Model NumberHEYEX 2 SW V2.2
Company DUNS329833875
Company NameHeidelberg Engineering GmbH
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 Batchfalse
Serial Numberfalse
Manufacturing Datetrue
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
GS104059237000242 [Primary]

FDA Product Code

HPTPerimeter, Automatic, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-12-16

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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