Fingerswitch Wand SIEC-3FHPB/D1

GUDID 00810026180613

Fingerswitch Wand, sterile, single use

SONIQUENCE, LLC

Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use
Primary Device ID00810026180613
NIH Device Record Key25a134fa-0d46-4100-b112-1c56da9d3057
Commercial Distribution StatusIn Commercial Distribution
Brand NameFingerswitch Wand
Version Model NumberSIEC-3FHPB/D1
Catalog NumberSIEC-3FHPB/D1
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810026180606 [Package]
Package: Blister Tray [10 Units]
In Commercial Distribution
GS100810026180613 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-08
Device Publish Date2020-04-30

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