OC-2400

GUDID 00850053428630

OC-2400 CHAIR CHOCOLATE 120 VOLT LOW; Ophthalmic examination chair

TOPCON HEALTHCARE INC

Ophthalmic chair, line-powered
Primary Device ID00850053428630
NIH Device Record Keyf8829052-74fc-4cd1-9916-980d4206233d
Commercial Distribution StatusIn Commercial Distribution
Brand NameOC-2400
Version Model Number24048-CO-L1-000
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
GS100850053428630 [Primary]

FDA Product Code

HMEChair, 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 Date2025-05-27
Device Publish Date2025-05-19

Devices Manufactured by TOPCON HEALTHCARE INC

00850053428630 - OC-24002025-05-27OC-2400 CHAIR CHOCOLATE 120 VOLT LOW; Ophthalmic examination chair
00850053428630 - OC-24002025-05-27 OC-2400 CHAIR CHOCOLATE 120 VOLT LOW; Ophthalmic examination chair
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