Edge X7 Ultra X7U350429S

GUDID 07640142444237

Edge X7 Ultra no 35, 04, 29mm

FKG Dentaire Sàrl

Rotary/reciprocating endodontic file/rasp, single-use

• Primary Device ID: 07640142444237
• NIH Device Record Key: bccbabad-81c5-4513-aa06-35c0afba8fe3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Edge X7 Ultra
• Version Model Number: X7U350429S
• Catalog Number: X7U350429S
• Company DUNS: 482884061
• Company Name: FKG Dentaire Sàrl
• Device Count: 6
• DM Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640142443780 [Primary]
GS1	07640142444237 [Unit of Use]
GS1	07640142445050 [Primary]

FDA Product Code

• EKS: File, Pulp Canal, 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: 2023-02-14
• Device Publish Date: 2023-02-06

On-Brand Devices [Edge X7 Ultra]

• 07640142444107: Edge X7 Ultra no 40, 04, 21mm
• 07640142444091: Edge X7 Ultra no 35, 04, 21mm
• 07640142444084: Edge X7 Ultra no 30, 04, 21mm
• 07640142444077: Edge X7 Ultra no 25, 04, 21mm
• 07640142444060: Edge X7 Ultra no 20, 04, 21mm
• 07640142444053: Edge X7 Ultra no 17, 04, 21mm
• 07640142444336: Edge X7 Ultra Assortment .06/25mm
• 07640142444268: Edge X7 Ultra Assortment .06/21mm
• 07640142444121: Edge X7 Ultra Assortment .04/25mm
• 07640142444466: Edge X7 Ultra no 45, 06, 29mm
• 07640142444459: Edge X7 Ultra no 40, 06, 29mm
• 07640142444442: Edge X7 Ultra no 35, 06, 29mm
• 07640142444435: Edge X7 Ultra no 30, 06, 29mm
• 07640142444428: Edge X7 Ultra no 25, 06, 29mm
• 07640142444411: Edge X7 Ultra no 20, 06, 29mm
• 07640142444404: Edge X7 Ultra no 17, 06, 29mm
• 07640142444398: Edge X7 Ultra no 45, 06, 25mm
• 07640142444381: Edge X7 Ultra no 40, 06, 25mm
• 07640142444374: Edge X7 Ultra no 35, 06, 25mm
• 07640142444367: Edge X7 Ultra no 30, 06, 25mm
• 07640142444350: Edge X7 Ultra no 25, 06, 25mm
• 07640142444343: Edge X7 Ultra no 20, 06, 25mm
• 07640142444329: Edge X7 Ultra no 45, 06, 21mm
• 07640142444312: Edge X7 Ultra no 40, 06, 21mm
• 07640142444305: Edge X7 Ultra no 35, 06, 21mm
• 07640142444299: Edge X7 Ultra no 30, 06, 21mm
• 07640142444282: Edge X7 Ultra no 25, 06, 21mm
• 07640142444275: Edge X7 Ultra no 20, 06, 21mm
• 07640142444251: Edge X7 Ultra no 45, 06, 29mm
• 07640142444244: Edge X7 Ultra no 40, 04, 29mm
• 07640142444237: Edge X7 Ultra no 35, 04, 29mm
• 07640142444220: Edge X7 Ultra no 30, 04, 29mm
• 07640142444213: Edge X7 Ultra no 25, 04, 29mm
• 07640142444206: Edge X7 Ultra no 20, 04, 29mm
• 07640142444190: Edge X7 Ultra no 17, 04, 29mm
• 07640142444183: Edge X7 Ultra no 45, 04, 25mm
• 07640142444176: Edge X7 Ultra no 40, 04, 25mm
• 07640142444169: Edge X7 Ultra no 35, 04, 25mm
• 07640142444152: Edge X7 Ultra no 30, 04, 25mm
• 07640142444145: Edge X7 Ultra no 25, 04, 25mm
• 07640142444138: Edge X7 Ultra no 20, 04, 25mm
• 07640142444114: Edge X7 Ultra no 45, 04, 21mm