SPECTRALIS

GUDID 04059237000044

Heidelberg Engineering GmbH

Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system
Primary Device ID04059237000044
NIH Device Record Key67ce2c28-d38e-4bfd-bcb2-80b5a755a105
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPECTRALIS
Version Model NumberSP-PWS-1000A
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
GS104059237000044 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MYCOphthalmoscope,Laser,Scanning

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [SPECTRALIS]

04059237000549Software with HEYEX 2 V6.10-US
04059237000525Software V6.10-US
04059237000501SP-PWS-1001A
04059237000358Product Famliy with HEYEX 2 SW V6.9b-US
04059237000341Product Family SW V6.9.1-US
04059237000310Product Family SW V6.8a-US
04059237000303Product Family SW V6.8-US
04059237000297SPEC-CAM-S2610
04059237000280SPEC-CAM-S2600
04059237000259Image Capture Module SW V1.2
04059237000211HMO
04059237000150UWF1
04059237000136WFO2
04059237000112VAO
04059237000105Product Family SW V6.6
04059237000099SPEC-CAM-S3610
04059237000082SPEC-CAM-S1610
04059237000075SPEC-TSP
04059237000068SP-PWS-2001A
04059237000051SP-PWS-2000A
04059237000044SP-PWS-1000A
04059237000037SPEC-CAM-S3600
04059237000020SPEC-CAM-S2000
04059237000013SPEC-CAM-S1600
04059237000594Software with HEYEX 2 V6.12_US
04059237000570Software 6.12_US
04059237000716SP-PWS-2001A [>20000]
04059237000488Software with HEYEX 2 V6.14_US
04059237000464Software 6.13_US
04059237000839Software with HEYEX 2 V7.0-US
04059237000815Software V7.0-US
04059237000891S2002
04059237000884S1002

Trademark Results [SPECTRALIS]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SPECTRALIS
SPECTRALIS
77037973 3284634 Live/Registered
Heidelberg Engineering, Inc.
2006-11-06

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