Edge One Fire GP

GUDID 88800069209486

EdgeOne Fire Gutta Percha Points LG

SURE DENT CORPORATION

Synthetic gutta-percha

• Primary Device ID: 88800069209486
• NIH Device Record Key: 7aa07bd9-7818-46c8-9c2f-9b44af37d06b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Edge One Fire GP
• Version Model Number: EOFLGGP-1
• Company DUNS: 688273010
• Company Name: SURE DENT CORPORATION
• Device Count: 60
• 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 away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature away from direct sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800069209480 [Primary]
GS1	88800069209486 [Unit of Use]

FDA Product Code

• EKM: Gutta-Percha

Sterilization

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

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 One Fire GP]

• 88800069209806: EDGEONE FIRE GUTTA PERCHA ASSORTED - (sm,pri,med,lg)
• 88800069209486: EdgeOne Fire Gutta Percha Points LG
• 88800069209479: EdgeOne Fire Gutta Percha Points MED
• 88800069209462: EdgeOne Fire Gutta Percha Points PRI
• 88800069209455: EdgeOne Fire Gutta Percha Points SM