CORE 500 Digital Stethoscope FIGS Earpiece - Sandstone CAC500_FSA

GUDID 00850010298276

CORE 500 Digital Stethoscope FIGS Earpiece - Sandstone

Eko Devices, Inc.

Electronic acoustic stethoscope
Primary Device ID00850010298276
NIH Device Record Key55578b89-f0ea-4437-ad5a-d44501163cf1
Commercial Distribution StatusIn Commercial Distribution
Brand NameCORE 500 Digital Stethoscope FIGS Earpiece - Sandstone
Version Model NumberE8
Catalog NumberCAC500_FSA
Company DUNS079670921
Company NameEko Devices, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100850010298276 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DPSElectrocardiograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-26
Device Publish Date2025-03-18

Devices Manufactured by Eko Devices, Inc.

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00850010298245 - CORE 500 Digital Stethoscope FIGS Earpiece - Black2025-03-26 CORE 500 Digital Stethoscope FIGS Earpiece - Black
00850010298252 - CORE 500 Digital Stethoscope FIGS Earpiece - Grey2025-03-26 CORE 500 Digital Stethoscope FIGS Earpiece - Grey
00850010298269 - CORE 500 Digital Stethoscope FIGS Earpiece - Mauve2025-03-26 CORE 500 Digital Stethoscope FIGS Earpiece - Mauve
00850010298276 - CORE 500 Digital Stethoscope FIGS Earpiece - Sandstone2025-03-26CORE 500 Digital Stethoscope FIGS Earpiece - Sandstone
00850010298276 - CORE 500 Digital Stethoscope FIGS Earpiece - Sandstone2025-03-26 CORE 500 Digital Stethoscope FIGS Earpiece - Sandstone
00850010298306 - CORE 500 Digital Stethoscope FIGS Earpiece - Royal Blue2025-03-26 CORE 500 Digital Stethoscope FIGS Earpiece - Royal Blue
00850010298313 - CORE 500 Digital Stethoscope FIGS Earpiece - Moss2025-03-26 CORE 500 Digital Stethoscope FIGS Earpiece - Moss
00850010298399 - CORE 500 Digital Stethoscope FIGS Earpiece - Pink Ribbon2025-03-26 CORE 500 Digital Stethoscope FIGS Earpiece - Pink Ribbon

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