GBT Machine Wireless Pedal

GUDID 07613353331184

GBT Machine Wireless Pedal

E.M.S. Electro Medical Systems S.A.

Foot-switch, electrical
Primary Device ID07613353331184
NIH Device Record Key33bc08fb-6f05-43fb-a6fa-9c63072faa87
Commercial Distribution StatusIn Commercial Distribution
Brand NameGBT Machine Wireless Pedal
Version Model NumberEK-1055B
Company DUNS481233849
Company NameE.M.S. Electro Medical Systems S.A.
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
GS107613353331184 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KOJAirbrush

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-24
Device Publish Date2026-02-16

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