Edge .04 PP

GUDID 88800069209523

Edge 04 Paper Points 30.04

SURE DENT CORPORATION

Endodontic paper point

• Primary Device ID: 88800069209523
• NIH Device Record Key: cc0eb0d1-9e45-46d1-a778-948723cc1e50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Edge .04 PP
• Version Model Number: SPP3004-1
• Company DUNS: 688273010
• Company Name: SURE DENT CORPORATION
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800069209527 [Primary]
GS1	88800069209523 [Unit of Use]

FDA Product Code

• EKN: Point, Paper, Endodontic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-24
• Device Publish Date: 2023-08-16

On-Brand Devices [Edge .04 PP]

• 88800069209813: EDGE X7 04 PAPER POINTS ASSORTED - (20,25,30,35,40,45)
• 88800069209561: Edge 04 Paper Points 50.04
• 88800069209554: Edge 04 Paper Points 45.04
• 88800069209547: Edge 04 Paper Points 40.04
• 88800069209530: Edge 04 Paper Points 35.04
• 88800069209523: Edge 04 Paper Points 30.04
• 88800069209516: Edge 04 Paper Points 25.04
• 88800069209509: Edge 04 Paper Points 20.04
• 88800069209493: Edge 04 Paper Points 15.04