SLIMLINE RECHARGEABLE HANDLE & BATTERY

GUDID 05055272719995

KEELER LIMITED

Retinoscope, line-powered
Primary Device ID05055272719995
NIH Device Record Key6d56cfb5-85b2-40d7-9a1c-915ca8439132
Commercial Distribution StatusIn Commercial Distribution
Brand NameSLIMLINE RECHARGEABLE HANDLE & BATTERY
Version Model Number1911-P-1201-500
Company DUNS210164398
Company NameKEELER LIMITED
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
GS105055272719995 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HKLRetinoscope, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-06
Device Publish Date2020-02-27

Devices Manufactured by KEELER LIMITED

05055272719674 - 532nm LIO2021-07-28
05055272720328 - 514/810nm LIO2021-07-28
05055272720380 - 577nm LIO2021-07-28
05055272719926 - 3.6V PROFESSIONAL OPHTH IN CASE2020-03-06
05055272719933 - 3.6V SPECIALIST OPHTH IN CASE2020-03-06
05055272719940 - 3.6V PROFESSIONAL STREAK RETINOSCOPE IN CASE2020-03-06
05055272719957 - 3.6V PROFESSIONAL STREAK LED RETINOSCOPE IN CASE2020-03-06
05055272719964 - US PROFESSIONAL LED STUDENT KIT-SLIM2020-03-06

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