AIT-250R

GUDID 00850003069616

AIT-250R TABLE FOR MAESTRO 2 R; AC-Powered Ophthalmic Instrument Table

TOPCON HEALTHCARE INC

Ophthalmic instrument table, line-powered
Primary Device ID00850003069616
NIH Device Record Keyb881208d-e8c7-406a-8709-03ef278de408
Commercial Distribution StatusIn Commercial Distribution
Brand NameAIT-250R
Version Model Number25042-11-002
Company DUNS053547238
Company NameTOPCON HEALTHCARE INC
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850003069616 [Primary]

FDA Product Code

HRJTable, Instrument, Powered, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-25
Device Publish Date2025-07-17

Devices Manufactured by TOPCON HEALTHCARE INC

00850003069616 - AIT-250R2025-07-25AIT-250R TABLE FOR MAESTRO 2 R; AC-Powered Ophthalmic Instrument Table
00850003069616 - AIT-250R2025-07-25 AIT-250R TABLE FOR MAESTRO 2 R; AC-Powered Ophthalmic Instrument Table
00850053428630 - OC-24002025-05-27 OC-2400 CHAIR CHOCOLATE 120 VOLT LOW; Ophthalmic examination chair
00850003069357 - Harmony2025-03-12 Harmony 5.07.004 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and stora
00850003069432 - Harmony2025-03-12 Harmony 5.08 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage o
00850003069500 - Harmony2025-03-12 Harmony 5.08.001 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and stora
00850003069517 - Harmony2025-03-12 Harmony 5.09 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage o
00850003069524 - Harmony2025-03-12 Harmony 5.09.001 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and stora
00850003069531 - Harmony2025-03-12 Harmony 6.0 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of
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