ANTERION

GUDID 04059237000938

Heidelberg Engineering GmbH

Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser
Primary Device ID04059237000938
NIH Device Record Keyb0014fa1-eebb-4624-a842-eeb9f8a30835
Commercial Distribution StatusIn Commercial Distribution
Brand NameANTERION
Version Model Number88036
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 Numbertrue
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
GS104059237000938 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OBOTomography, Optical Coherence

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-27
Device Publish Date2023-11-18

On-Brand Devices [ANTERION]

0405923700061788036
04059237000754Software with HEYEX 2 V1.2.3
0405923700087788036
04059237000945Software V.1.2.4 US
0405923700093888036

Trademark Results [ANTERION]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ANTERION
ANTERION
79222790 5624707 Live/Registered
Heidelberg Engineering GmbH
2017-10-24

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