GentleWave G4 Support Arm GW-ARM-0001

GUDID 00858395006769

SONENDO, INC.

Dental delivery system instrument unit, electric
Primary Device ID00858395006769
NIH Device Record Key49ec3041-0415-4b09-99b4-13f2f1e0a5ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameGentleWave G4 Support Arm
Version Model NumberFG-012-00002
Catalog NumberGW-ARM-0001
Company DUNS828894373
Company NameSONENDO, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100858395006769 [Primary]

FDA Product Code

EIFAccessories, Retractor, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-04
Device Publish Date2023-04-26

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00810209420536 - FlowLogic Assert2026-01-05 FlowLogic Assert Shaping File 15/.04, 31mm
00810209420543 - FlowLogic Assert2026-01-05 FlowLogic Assert Shaping File 15/.06, 21mm
00810209420550 - FlowLogic Assert2026-01-05 FlowLogic Assert Shaping File 15/.06, 25mm
00810209420567 - FlowLogic Assert2026-01-05 FlowLogic Assert Shaping File 15/.06, 31mm

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