Edge .06 GP

GUDID 88800069209349

Edge 06 Gutta Percha Points 25.06

SURE DENT CORPORATION

Synthetic gutta-percha
Primary Device ID88800069209349
NIH Device Record Key05b816e8-0fae-4f4a-852e-01658c7d960e
Commercial Distribution StatusIn Commercial Distribution
Brand NameEdge .06 GP
Version Model NumberSGP2506-1
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
GS108800069209343 [Primary]
GS188800069209349 [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 .06 GP]

88800069209783EDGE 06 GUTTA PERCHA ASSORTED - (20,25,30,35,40,45)
88800069209394Edge 06 Gutta Percha Points 50.06
88800069209387Edge 06 Gutta Percha Points 45.06
88800069209370Edge 06 Gutta Percha Points 40.06
88800069209363Edge 06 Gutta Percha Points 35.06
88800069209356Edge 06 Gutta Percha Points 30.06
88800069209349Edge 06 Gutta Percha Points 25.06
88800069209332Edge 06 Gutta Percha Points 20.06
88800069209325Edge 06 Gutta Percha Points 15.06

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.