PSL One

GUDID 05055272711777

KEELER LIMITED

Ophthalmic slit lamp, examination
Primary Device ID05055272711777
NIH Device Record Keya4b8ebca-c313-4d05-98c0-7e0f391d40b1
Commercial Distribution StatusIn Commercial Distribution
Brand NamePSL One
Version Model Number3010-P-2001
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 Batchfalse
Serial Numbertrue
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
GS105055272711777 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HJOBiomicroscope, Slit-Lamp, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-08

Devices Manufactured by KEELER LIMITED

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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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