1DIAL CONTROLLER KB-50S

GUDID 04560126268570

TOPCON CORPORATION

Phoropter, electric
Primary Device ID04560126268570
NIH Device Record Keyff5e378e-dcde-4f7f-9bba-b7625cd6cb56
Commercial Distribution StatusIn Commercial Distribution
Brand Name1DIAL CONTROLLER KB-50S
Version Model NumberKB-50S
Company DUNS690542881
Company NameTOPCON CORPORATION
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 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
GS104560126268570 [Primary]

FDA Product Code

HKNRefractor, Manual, Non-Powered, Including Phoropter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-07
Device Publish Date2025-02-27

Devices Manufactured by TOPCON CORPORATION

04560126268495 - SightPilot NAVi Contoller SNi-1 for COMPU VISION CV-50002025-03-07
04560126268532 - COMPU VISION CV-50002025-03-07
04560126268549 - COMPU VISION CV-50002025-03-07
04560126268570 - 1DIAL CONTROLLER KB-50S2025-03-07
04560126268570 - 1DIAL CONTROLLER KB-50S2025-03-07
04560126268624 - POWER SUPPLY UNIT for CV-5000 (PC EXTERNAL TYPE)2025-03-07
04560126268648 - POWER SUPPLY UNIT for CV-5000 (BUILT-IN PC TYPE)2025-03-07
04571130282773 - REFRACTION SYSTEM Chronos2024-08-09
04571130283350 - AUTO KERATO-REFRACTOMETER KR-8002024-05-17

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