ANTERIOR ATTACHMENT HA-2

GUDID 04571130282186

TOPCON CORPORATION

Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system
Primary Device ID04571130282186
NIH Device Record Key305f2d2b-8b8d-45cc-940a-0d1539d0fcf1
Commercial Distribution StatusIn Commercial Distribution
Brand NameANTERIOR ATTACHMENT HA-2
Version Model NumberHA-2
Company DUNS690542881
Company NameTOPCON CORPORATION
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
GS104571130282186 [Primary]

FDA Product Code

HKICamera, ophthalmic, ac-powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-11
Device Publish Date2021-02-03

Devices Manufactured by TOPCON CORPORATION

04562123288384 - COMPUTERIZED LENSMETER CL-3002023-12-27
04562123288391 - COMPUTERIZED LENSMETER CL-3002023-12-27
04560126268198 - Chinrest CRX-1000 for REFRACTION SYSTEM Chronos2023-11-24
04560126264640 - INFRARED COMMUNICATION UNIT2022-09-08
04560126266071 - KR-1W Viewer2022-09-08
04562123280531 - PRISM COMPENSATOR for LENSMETER LM-82022-09-08
04562123286441 - TL-5A2022-09-08
04562123286465 - OBLIQUE ILLUMINATOR MS-OI042022-09-08

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.