SP-Kit SSP-01

GUDID 00810026181016

Fingerswitch Wand & 4 SP-Tips

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 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 ID00810026181016
NIH Device Record Key9ca34e7e-ce73-412e-95c8-96e3e50d51dc
Commercial Distribution StatusIn Commercial Distribution
Brand NameSP-Kit
Version Model NumberSSP-01
Catalog NumberSSP-01
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
GS100810026181016 [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 Date2021-01-22
Device Publish Date2021-01-14

Devices Manufactured by SONIQUENCE, LLC

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00810026183775 - Bleph kit2023-10-16 Bleph Kit
00810026180248 - Blepharoplasty kit2023-04-04 Blepharoplasty Kit
00810026180972 - Reusable Handpiece2023-04-04 Reusable Handpiece
00810026181535 - RF Generator2023-04-04 RF Generator
00810026181542 - RF Generator2023-04-04 RF Generator
00810026181559 - RF Generator2023-04-04 RF Generator

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