Edge Taper GP

GUDID 88800069209417

Edge Taper Gutta Percha Points F2

SURE DENT CORPORATION

Synthetic gutta-percha
Primary Device ID88800069209417
NIH Device Record Keye3550f7a-64d4-4fb6-9a16-9a4bbd4ef3dc
Commercial Distribution StatusIn Commercial Distribution
Brand NameEdge Taper GP
Version Model NumberETGPF2-1
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
GS108800069209411 [Primary]
GS188800069209417 [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 Taper GP]

88800069209790EDGE TAPER GUTTA PERCHA ASSORTED - (F1-F5)
88800069209448Edge Taper Gutta Percha Points F5
88800069209431Edge Taper Gutta Percha Points F4
88800069209424Edge Taper Gutta Percha Points F3
88800069209417Edge Taper Gutta Percha Points F2
88800069209400Edge Taper Gutta Percha Points F1

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