Edge X7 Ultra X7U300621S

GUDID 07640142444299

Edge X7 Ultra no 30, 06, 21mm

FKG Dentaire Sàrl

Rotary/reciprocating endodontic file/rasp, single-use
Primary Device ID07640142444299
NIH Device Record Keya3b5cb32-312b-4d84-b20d-1d07f311cf48
Commercial Distribution StatusIn Commercial Distribution
Brand NameEdge X7 Ultra
Version Model NumberX7U300621S
Catalog NumberX7U300621S
Company DUNS482884061
Company NameFKG Dentaire Sàrl
Device Count6
DM Exempttrue
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 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
GS107640142443858 [Primary]
GS107640142444299 [Unit of Use]
GS107640142445111 [Primary]

FDA Product Code

EKSFile, Pulp Canal, Endodontic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-14
Device Publish Date2023-02-06

On-Brand Devices [Edge X7 Ultra]

07640142444107Edge X7 Ultra no 40, 04, 21mm
07640142444091Edge X7 Ultra no 35, 04, 21mm
07640142444084Edge X7 Ultra no 30, 04, 21mm
07640142444077Edge X7 Ultra no 25, 04, 21mm
07640142444060Edge X7 Ultra no 20, 04, 21mm
07640142444053Edge X7 Ultra no 17, 04, 21mm
07640142444336Edge X7 Ultra Assortment .06/25mm
07640142444268Edge X7 Ultra Assortment .06/21mm
07640142444121Edge X7 Ultra Assortment .04/25mm
07640142444466Edge X7 Ultra no 45, 06, 29mm
07640142444459Edge X7 Ultra no 40, 06, 29mm
07640142444442Edge X7 Ultra no 35, 06, 29mm
07640142444435Edge X7 Ultra no 30, 06, 29mm
07640142444428Edge X7 Ultra no 25, 06, 29mm
07640142444411Edge X7 Ultra no 20, 06, 29mm
07640142444404Edge X7 Ultra no 17, 06, 29mm
07640142444398Edge X7 Ultra no 45, 06, 25mm
07640142444381Edge X7 Ultra no 40, 06, 25mm
07640142444374Edge X7 Ultra no 35, 06, 25mm
07640142444367Edge X7 Ultra no 30, 06, 25mm
07640142444350Edge X7 Ultra no 25, 06, 25mm
07640142444343Edge X7 Ultra no 20, 06, 25mm
07640142444329Edge X7 Ultra no 45, 06, 21mm
07640142444312Edge X7 Ultra no 40, 06, 21mm
07640142444305Edge X7 Ultra no 35, 06, 21mm
07640142444299Edge X7 Ultra no 30, 06, 21mm
07640142444282Edge X7 Ultra no 25, 06, 21mm
07640142444275Edge X7 Ultra no 20, 06, 21mm
07640142444251Edge X7 Ultra no 45, 06, 29mm
07640142444244Edge X7 Ultra no 40, 04, 29mm
07640142444237Edge X7 Ultra no 35, 04, 29mm
07640142444220Edge X7 Ultra no 30, 04, 29mm
07640142444213Edge X7 Ultra no 25, 04, 29mm
07640142444206Edge X7 Ultra no 20, 04, 29mm
07640142444190Edge X7 Ultra no 17, 04, 29mm
07640142444183Edge X7 Ultra no 45, 04, 25mm
07640142444176Edge X7 Ultra no 40, 04, 25mm
07640142444169Edge X7 Ultra no 35, 04, 25mm
07640142444152Edge X7 Ultra no 30, 04, 25mm
07640142444145Edge X7 Ultra no 25, 04, 25mm
07640142444138Edge X7 Ultra no 20, 04, 25mm
07640142444114Edge X7 Ultra no 45, 04, 21mm
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