Traxodent - Itena 7007091

GUDID 00348783001006

Traxodent Value Pack - ITENA

PREMIER DENTAL PRODUCTS COMPANY

Gingival retraction solution Gingival retraction solution Gingival retraction solution Gingival retraction solution Gingival retraction solution Gingival retraction solution Gingival retraction solution Gingival retraction solution Gingival retraction solution Gingival retraction solution Gingival retraction solution Gingival retraction solution Gingival retraction solution Gingival retraction solution Gingival retraction solution Gingival retraction solution Gingival retraction solution Gingival retraction solution

• Primary Device ID: 00348783001006
• NIH Device Record Key: 758d292d-e917-49dc-b8ce-30f18b36a8f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Traxodent - Itena
• Version Model Number: TRAPACK-25
• Catalog Number: 7007091
• Company DUNS: 014789663
• Company Name: PREMIER DENTAL PRODUCTS COMPANY
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	00348783001006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083695

FDA Product Code

• MVL: Cord, Retraction

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: 2023-10-24
• Device Publish Date: 2023-10-16

On-Brand Devices [Traxodent - Itena]

• 00348783001020: Traxodent Trial (2 pack) - ITENA
• 00348783001013: Traxodent Starter Pack - ITENA
• 00348783001006: Traxodent Value Pack - ITENA