Primary Device ID | 00858395006769 |
NIH Device Record Key | 49ec3041-0415-4b09-99b4-13f2f1e0a5ce |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | GentleWave G4 Support Arm |
Version Model Number | FG-012-00002 |
Catalog Number | GW-ARM-0001 |
Company DUNS | 828894373 |
Company Name | SONENDO, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 8447663636 |
info@sonendo.com | |
Phone | 8447663636 |
info@sonendo.com | |
Phone | 8447663636 |
info@sonendo.com | |
Phone | 8447663636 |
info@sonendo.com | |
Phone | 8447663636 |
info@sonendo.com | |
Phone | 8447663636 |
info@sonendo.com | |
Phone | 8447663636 |
info@sonendo.com | |
Phone | 8447663636 |
info@sonendo.com | |
Phone | 8447663636 |
info@sonendo.com | |
Phone | 8447663636 |
info@sonendo.com | |
Phone | 8447663636 |
info@sonendo.com | |
Phone | 8447663636 |
info@sonendo.com | |
Phone | 8447663636 |
info@sonendo.com | |
Phone | 8447663636 |
info@sonendo.com | |
Phone | 8447663636 |
info@sonendo.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00858395006769 [Primary] |
EIF | Accessories, Retractor, Dental |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-05-04 |
Device Publish Date | 2023-04-26 |
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00858395006769 - GentleWave G4 Support Arm | 2023-05-04 |
00858395006769 - GentleWave G4 Support Arm | 2023-05-04 |
00858395006783 - Posterior CleanFlow Procedure Instrument with Matrix | 2023-05-04 CleanFlow Device used with the GentleWave System to treat root canals (Posterior teeth). |
00195893912278 - Posterior CleanFlow Procedure Instrument with Matrices | 2022-11-02 Posterior CleanFlow Procedure Instrument with Matrices (Singles) |
00858395006622 - GentleWave G4 Console | 2022-11-02 |
00858395006745 - Posterior Cleanflow Matrices | 2022-11-02 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 Matrix | 2020-10-28 Premolar CrossFire Procedure Instrument with Matrix, when used with the Sonendo GentleWave Console, is intended to be used on th |