Edge .04 GP

GUDID 88800069209318

Edge 04 Gutta Percha Points 50.04

SURE DENT CORPORATION

Synthetic gutta-percha
Primary Device ID88800069209318
NIH Device Record Key7c23c0e0-c925-4535-ac14-f5c4dfe346e4
Commercial Distribution StatusIn Commercial Distribution
Brand NameEdge .04 GP
Version Model NumberSGP5004-1
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
GS108800069209312 [Primary]
GS188800069209318 [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 .04 GP]

88800069209776EDGE 04 GUTTA PERCHA ASSORTED - (20,25,30,35,40,45)
88800069209318Edge 04 Gutta Percha Points 50.04
88800069209301Edge 04 Gutta Percha Points 45.04
88800069209295Edge 04 Gutta Percha Points 40.04
88800069209288Edge 04 Gutta Percha Points 35.04
88800069209271Edge 04 Gutta Percha Points 30.04
88800069209264Edge 04 Gutta Percha Points 25.04
88800069209257Edge 04 Gutta Percha Points 20.04
88800069209240Edge 04 Gutta Percha Points 15.04

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