Dual Footswitch SDF-FSCB

GUDID 00810026180927

Dual Footswitch (Monopolar Cut/Blend & Bipolar Hemo/Bipolar)

SONIQUENCE, LLC

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Primary Device ID00810026180927
NIH Device Record Key89c249a5-0b4f-42fb-baee-42732a992ab6
Commercial Distribution StatusIn Commercial Distribution
Brand NameDual Footswitch
Version Model NumberSDF-FSCB
Catalog NumberSDF-FSCB
Company DUNS117308190
Company NameSONIQUENCE, LLC
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810026180927 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-27
Device Publish Date2021-09-19

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