FlowLogic Assert FLG15C0631

GUDID 00810209420567

FlowLogic Assert Shaping File 15/.06, 31mm

SONENDO, INC.

Rotary/reciprocating endodontic file/rasp, single-use
Primary Device ID00810209420567
NIH Device Record Key50e9fc17-69cd-4cee-a171-234b9611ab17
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlowLogic Assert
Version Model NumberFG-016-00007-65
Catalog NumberFLG15C0631
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store files in a clean, dry, and dust-free place
Special Storage Condition, SpecifyBetween 0 and 0 *Store files in a clean, dry, and dust-free place
Special Storage Condition, SpecifyBetween 0 and 0 *Store files in a clean, dry, and dust-free place
Special Storage Condition, SpecifyBetween 0 and 0 *Store files in a clean, dry, and dust-free place
Special Storage Condition, SpecifyBetween 0 and 0 *Store files in a clean, dry, and dust-free place
Special Storage Condition, SpecifyBetween 0 and 0 *Store files in a clean, dry, and dust-free place
Special Storage Condition, SpecifyBetween 0 and 0 *Store files in a clean, dry, and dust-free place
Special Storage Condition, SpecifyBetween 0 and 0 *Store files in a clean, dry, and dust-free place
Special Storage Condition, SpecifyBetween 0 and 0 *Store files in a clean, dry, and dust-free place
Special Storage Condition, SpecifyBetween 0 and 0 *Store files in a clean, dry, and dust-free place
Special Storage Condition, SpecifyBetween 0 and 0 *Store files in a clean, dry, and dust-free place

Device Identifiers

Device Issuing AgencyDevice ID
GS100810209420567 [Primary]

FDA Product Code

EKSFile, Pulp Canal, Endodontic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810209420567]

Moist Heat or Steam Sterilization

[00810209420567]

Moist Heat or Steam Sterilization

[00810209420567]

Moist Heat or Steam Sterilization

[00810209420567]

Moist Heat or Steam Sterilization

[00810209420567]

Moist Heat or Steam Sterilization

[00810209420567]

Moist Heat or Steam Sterilization

[00810209420567]

Moist Heat or Steam Sterilization

[00810209420567]

Moist Heat or Steam Sterilization

[00810209420567]

Moist Heat or Steam Sterilization

[00810209420567]

Moist Heat or Steam Sterilization

[00810209420567]

Moist Heat or Steam Sterilization

[00810209420567]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-01-05
Device Publish Date2025-12-26

On-Brand Devices [FlowLogic Assert]

00810209420840FlowLogic Assert Shaping File 40/.04, 21mm
00810209420789FlowLogic Assert Shaping File 35/.04, 21mm
00810209420727FlowLogic Assert Shaping File 30/.04, 21mm
00810209420673FlowLogic Assert Shaping File 25/.04, 25mm
00810209420666FlowLogic Assert Shaping File 25/.04, 21mm
00810209420611FlowLogic Assert Shaping File 20/.04, 25mm
00810209420604FlowLogic Assert Shaping File 20/.04, 21mm
00810209420598FlowLogic Assert Shaping File 16/.02, 31mm
00810209420581FlowLogic Assert Shaping File 16/.02, 25mm
00810209420574FlowLogic Assert Shaping File 16/.02, 21mm
00810209420529FlowLogic Assert Shaping File 15/.04, 25mm
00810209420512FlowLogic Assert Shaping File 15/.04, 21mm
00810209420505FlowLogic Assert Shaping File 13/.02, 31mm
00810209420499FlowLogic Assert Shaping File 13/.02, 25mm
00810209420482FlowLogic Assert Shaping File 13/.02, 21mm
00810209420444FlowLogic Assert Shaping File 10/.04, 25mm
00810209420437FlowLogic Assert Shaping File 10/.04, 21mm
00810209421359FlowLogic Assert Shaping File Variable Kit, 25mm
00810209421342FlowLogic Assert Shaping File Variable Kit, 21mm
00810209421335FlowLogic Assert Shaping File 25 Variable, 31mm
00810209421328FlowLogic Assert Shaping File 20 Variable, 31mm
00810209421311FlowLogic Assert Shaping File 17 Variable, 31mm
00810209421304FlowLogic Assert Shaping File 14 Variable, 31mm
00810209421298FlowLogic Assert Shaping File 12 Variable, 31mm
00810209421281FlowLogic Assert Shaping File 10 Variable, 31mm
00810209421274FlowLogic Assert Shaping File 25 Variable, 25mm
00810209421267FlowLogic Assert Shaping File 20 Variable, 25mm
00810209421250FlowLogic Assert Shaping File 17 Variable, 25mm
00810209421243FlowLogic Assert Shaping File 14 Variable, 25mm
00810209421236FlowLogic Assert Shaping File 12 Variable, 25mm
00810209421229FlowLogic Assert Shaping File 10 Variable, 25mm
00810209421212FlowLogic Assert Shaping File 25 Variable, 21mm
00810209421205FlowLogic Assert Shaping File 20 Variable, 21mm
00810209421199FlowLogic Assert Shaping File 17 Variable, 21mm
00810209421182FlowLogic Assert Shaping File 14 Variable, 21mm
00810209421175FlowLogic Assert Shaping File 12 Variable, 21mm
00810209421168FlowLogic Assert Shaping File 10 Variable, 21mm
00810209420956FlowLogic Assert Shaping File .04 Kit, 25mm
00810209420949FlowLogic Assert Shaping File .04 Kit, 21mm
00810209420895FlowLogic Assert Shaping File 40/.06, 31mm
00810209420888FlowLogic Assert Shaping File 40/.06, 25mm
00810209420871FlowLogic Assert Shaping File 40/.06, 21mm
00810209420864FlowLogic Assert Shaping File 40/.04, 31mm
00810209420857FlowLogic Assert Shaping File 40/.04, 25mm
00810209420833FlowLogic Assert Shaping File 35/.06, 31mm
00810209420826FlowLogic Assert Shaping File 35/.06, 25mm
00810209420819FlowLogic Assert Shaping File 35/.06, 21mm
00810209420802FlowLogic Assert Shaping File 35/.04, 31mm
00810209420796FlowLogic Assert Shaping File 35/.04, 25mm
00810209420772FlowLogic Assert Shaping File 30/.06, 31mm
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