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

Devices Manufactured by SONENDO, INC.

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00858395006769 - GentleWave G4 Support Arm2023-05-04
00858395006769 - GentleWave G4 Support Arm2023-05-04
00858395006783 - Posterior CleanFlow Procedure Instrument with Matrix2023-05-04 CleanFlow Device used with the GentleWave System to treat root canals (Posterior teeth).
00195893912278 - Posterior CleanFlow Procedure Instrument with Matrices2022-11-02 Posterior CleanFlow Procedure Instrument with Matrices (Singles)
00858395006622 - GentleWave G4 Console2022-11-02
00858395006745 - Posterior Cleanflow Matrices2022-11-02 Posterior Cleanflow Matrices (10 Pack)
00858395006707 - Posterior CleanFlow Procedure Instrument with Matrices 2022-11-02 Posterior CleanFlow Procedure Instrument with Matrices (10-Pack)
00858395006646 - Premolar CrossFire Procedure Instrument with Matrix2020-10-28 Premolar CrossFire Procedure Instrument with Matrix, when used with the Sonendo GentleWave Console, is intended to be used on th

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