EdgeDiamond Utopia EDU2507V25

GUDID 07640142446606

EdgeDiamond Utopia - F2, no 25, 07v, 25 mm

FKG Dentaire Sàrl

Rotary/reciprocating endodontic file/rasp, single-use
Primary Device ID07640142446606
NIH Device Record Keyc3db2de9-a888-4d9d-a8ab-dc01d84bed9b
Commercial Distribution StatusIn Commercial Distribution
Brand NameEdgeDiamond Utopia
Version Model NumberEDU2507V25
Catalog NumberEDU2507V25
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
GS107640142446392 [Primary]
GS107640142446606 [Unit of Use]

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 Date2024-11-26
Device Publish Date2024-11-18

On-Brand Devices [EdgeDiamond Utopia]

07640142446521EdgeDiamond Utopia Assortment, 31 mm
07640142446514EdgeDiamond Utopia Assortment, 25 mm
07640142446507EdgeDiamond Utopia Assortment, 21 mm
07640142446705EdgeDiamond Utopia - FXL, no 50, 07v, 31 mm
07640142446699EdgeDiamond Utopia - FXL, no 50, 07v, 25 mm
07640142446682EdgeDiamond Utopia - FXL, no 50, 07v, 21 mm
07640142446675EdgeDiamond Utopia - FX, no 35, 07v, 31 mm
07640142446668EdgeDiamond Utopia - FX, no 35, 07v, 25 mm
07640142446651EdgeDiamond Utopia - FX, no 35, 07v, 21 mm
07640142446644EdgeDiamond Utopia - F3, no 30, 07v, 31 mm
07640142446637EdgeDiamond Utopia - F3, no 30, 07v, 25 mm
07640142446620EdgeDiamond Utopia - F3, no 30, 07v, 21 mm
07640142446613EdgeDiamond Utopia - F2, no 25, 07v, 31 mm
07640142446606EdgeDiamond Utopia - F2, no 25, 07v, 25 mm
07640142446590EdgeDiamond Utopia - F2, no 25, 07v, 21 mm
07640142446583EdgeDiamond Utopia - F1, no 20, 07v, 31 mm
07640142446576EdgeDiamond Utopia - F1, no 20, 07v, 25 mm
07640142446569EdgeDiamond Utopia - F1, no 20, 07v, 21 mm
07640142446552EdgeDiamond Utopia - Shaper, no 20, 04v, 31 mm
07640142446538EdgeDiamond Utopia - Shaper, no 20, 04v, 25 mm

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