EdgeDiamond Utopia EDU3007V31

GUDID 07640142446644

EdgeDiamond Utopia - F3, no 30, 07v, 31 mm

FKG Dentaire Sàrl

Rotary/reciprocating endodontic file/rasp, single-use

• Primary Device ID: 07640142446644
• NIH Device Record Key: 98ce7a0a-27a4-4c8a-80db-30736e5b0979
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EdgeDiamond Utopia
• Version Model Number: EDU3007V31
• Catalog Number: EDU3007V31
• 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	07640142446439 [Primary]
GS1	07640142446644 [Unit of Use]

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: 2024-11-26
• Device Publish Date: 2024-11-18

On-Brand Devices [EdgeDiamond Utopia]

• 07640142446521: EdgeDiamond Utopia Assortment, 31 mm
• 07640142446514: EdgeDiamond Utopia Assortment, 25 mm
• 07640142446507: EdgeDiamond Utopia Assortment, 21 mm
• 07640142446705: EdgeDiamond Utopia - FXL, no 50, 07v, 31 mm
• 07640142446699: EdgeDiamond Utopia - FXL, no 50, 07v, 25 mm
• 07640142446682: EdgeDiamond Utopia - FXL, no 50, 07v, 21 mm
• 07640142446675: EdgeDiamond Utopia - FX, no 35, 07v, 31 mm
• 07640142446668: EdgeDiamond Utopia - FX, no 35, 07v, 25 mm
• 07640142446651: EdgeDiamond Utopia - FX, no 35, 07v, 21 mm
• 07640142446644: EdgeDiamond Utopia - F3, no 30, 07v, 31 mm
• 07640142446637: EdgeDiamond Utopia - F3, no 30, 07v, 25 mm
• 07640142446620: EdgeDiamond Utopia - F3, no 30, 07v, 21 mm
• 07640142446613: EdgeDiamond Utopia - F2, no 25, 07v, 31 mm
• 07640142446606: EdgeDiamond Utopia - F2, no 25, 07v, 25 mm
• 07640142446590: EdgeDiamond Utopia - F2, no 25, 07v, 21 mm
• 07640142446583: EdgeDiamond Utopia - F1, no 20, 07v, 31 mm
• 07640142446576: EdgeDiamond Utopia - F1, no 20, 07v, 25 mm
• 07640142446569: EdgeDiamond Utopia - F1, no 20, 07v, 21 mm
• 07640142446552: EdgeDiamond Utopia - Shaper, no 20, 04v, 31 mm
• 07640142446538: EdgeDiamond Utopia - Shaper, no 20, 04v, 25 mm