Traxodent

GUDID D691TRAEMB20

Itena Traxodent Applicator Tip Qty 20

PREMIER DENTAL PRODUCTS COMPANY

Dental material injection cannula, single-use

• Primary Device ID: D691TRAEMB20
• NIH Device Record Key: b7c595cc-fe24-4151-9e6a-f1e48b0f0213
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Traxodent
• Version Model Number: TRAEMB20
• Company DUNS: 014789663
• Company Name: PREMIER DENTAL PRODUCTS COMPANY
• 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: true
• Manufacturing Date: false
• 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
HIBCC	D691TRAEMB20 [Primary]

FDA Product Code

• KXR: Applicator, Resin

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: 2022-07-07
• Device Publish Date: 2022-06-29

On-Brand Devices [Traxodent]

• D691TRAEMB60: Itena Traxodent Applicator Tip Qty 60
• D691TRAEMB20: Itena Traxodent Applicator Tip Qty 20
• D6919007092: Traxodent Applicator Tip
• 00348783013283: Traxodent Unit Dose Value Pack