Edge Taper PP

GUDID 88800069209677

Edge Taper Paper Points F3

SURE DENT CORPORATION

Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point
Primary Device ID88800069209677
NIH Device Record Key97237e9d-bc0d-4112-9b60-87d6b89249f4
Commercial Distribution StatusIn Commercial Distribution
Brand NameEdge Taper PP
Version Model NumberETPPF3-1
Company DUNS688273010
Company NameSURE DENT CORPORATION
Device Count100
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.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.

Device Identifiers

Device Issuing AgencyDevice ID
GS108800069209671 [Primary]
GS188800069209677 [Unit of Use]

FDA Product Code

EKNPoint, Paper, Endodontic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

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 PP]

88800069209837EDGE TAPER PAPER POINTS ASSORTED - (F1-F5)
88800069209691Edge Taper Paper Points F5
88800069209684Edge Taper Paper Points F4
88800069209677Edge Taper Paper Points F3
88800069209660Edge Taper Paper Points F2
88800069209653Edge Taper Paper Points F1

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