Firefly Global

GUDID 00851289007286

Otoscope Specula

Firefly Global

Otoscope, direct
Primary Device ID00851289007286
NIH Device Record Key6f1a2bb4-c116-4e65-a64f-52a3f4addbd6
Commercial Distribution StatusIn Commercial Distribution
Brand NameFirefly Global
Version Model NumberES120
Company DUNS020089936
Company NameFirefly Global
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 Usetrue
Lot Batchtrue
Serial Numberfalse
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
GS100851289007286 [Primary]

FDA Product Code

ERAOtoscope

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-24
Device Publish Date2023-10-16

On-Brand Devices [Firefly Global]

00851289007217Otoscope Specula
00851289007231Otoscope Specula
00851289007286Otoscope Specula

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