FenderWedge & FenderMate 602679

GUDID 17310236026799

Directa AB

Dental wedge, single-use Dental wedge, single-use Dental wedge, single-use Dental wedge, single-use Dental wedge, single-use Dental wedge, single-use Dental wedge, single-use Dental wedge, single-use Dental wedge, single-use Dental wedge, single-use Dental wedge, single-use Dental wedge, single-use Dental wedge, single-use Dental wedge, single-use Dental wedge, single-use Dental wedge, single-use Dental wedge, single-use Dental wedge, single-use Dental wedge, single-use Dental wedge, single-use Dental wedge, single-use

• Primary Device ID: 17310236026799
• NIH Device Record Key: ea35bc3c-4f52-4974-b9c3-398735f36c4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FenderWedge & FenderMate
• Version Model Number: Intro-Kit
• Catalog Number: 602679
• Company DUNS: 353954381
• Company Name: Directa AB
• Device Count: 1
• 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: true
• Expiration Date: false
• 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	17310236026799 [Primary]

FDA Product Code

• JEP: Retainer, Matrix

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: 2022-12-15
• Device Publish Date: 2022-12-07

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• 17310230021325 - Luxator: 2022-12-15 17310231050461 17310231050430 17310231050416 17310231050454 17310231050478 17310231050447 17310231050423
• 17310230021332 - Luxator: 2022-12-15 17310231050485 17310231050461 17310231050430 17310231050416 17310231050454