Edge X7 GP

GUDID 88800069209127

Edge X7 Gutta Percha Points 20.06

SURE DENT CORPORATION

Synthetic gutta-percha
Primary Device ID88800069209127
NIH Device Record Key3b77bc8b-1fb5-4f2d-8855-0f9590c3b314
Commercial Distribution StatusIn Commercial Distribution
Brand NameEdge X7 GP
Version Model NumberX72006GP-1
Company DUNS688273010
Company NameSURE DENT CORPORATION
Device Count60
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature away from direct sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS108800069209121 [Primary]
GS188800069209127 [Unit of Use]

FDA Product Code

EKMGutta-Percha

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-24
Device Publish Date2023-08-16

On-Brand Devices [Edge X7 GP]

88800069209752EDGE X7 .06 GUTTA PERCHA ASSORTED - (17,20,25,30,35,40)
88800069209745EDGE X7 .04 GUTTA PERCHA ASSORTED - (17,20,25,30,35,40)
88800069209172Edge X7 Gutta Percha Points 45.06
88800069209165Edge X7 Gutta Percha Points 40.06
88800069209158Edge X7 Gutta Percha Points 35.06
88800069209141Edge X7 Gutta Percha Points 30.06
88800069209134Edge X7 Gutta Percha Points 25.06
88800069209127Edge X7 Gutta Percha Points 20.06
88800069209110Edge X7 Gutta Percha Points 17.06
88800069209103Edge X7 Gutta Percha Points 45.04
88800069209097Edge X7 Gutta Percha Points 40.04
88800069209080Edge X7 Gutta Percha Points 35.04
88800069209073Edge X7 Gutta Percha Points 30.04
88800069209066Edge X7 Gutta Percha Points 25.04
88800069209059Edge X7 Gutta Percha Points 20.04
88800069209042Edge X7 Gutta Percha Points 17.04

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