Spectra Iris & large black frame

GUDID 05055272711791

KEELER LIMITED

Indirect binocular ophthalmoscope, line-powered
Primary Device ID05055272711791
NIH Device Record Key51f0516e-09d9-4573-ba34-56e62a325e19
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpectra Iris & large black frame
Version Model Number1205-P-2011
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
GS105055272711791 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HLJOphthalmoscope, Battery-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 Date2016-08-16

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