Traxodent Gel FS - Bulk Syringe Kit

GUDID 10818207025002

Vista Dental

Gingival retraction solution

• Primary Device ID: 10818207025002
• NIH Device Record Key: 60968145-d9d7-498b-ae5e-69085f1ec229
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Traxodent Gel FS - Bulk Syringe Kit
• Version Model Number: 9007106
• Company DUNS: 036623932
• Company Name: Vista Dental
• Device Count: 1
• DM Exempt: true
• 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10818207025002 [Primary]

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: 2025-07-08
• Device Publish Date: 2025-06-30

Devices Manufactured by Vista Dental

• 10818207024968 - Traxodent Gel AlCl - Bulk Syringe Kit: 2025-07-08
• 10818207024975 - Traxodent Gel AlCl - Sample Pack: 2025-07-08
• 10818207024982 - Traxodent Gel AlCl - Value Pack: 2025-07-08
• 10818207024999 - Traxodent Gel AlCl - Refill Kit: 2025-07-08
• 10818207025002 - Traxodent Gel FS - Bulk Syringe Kit: 2025-07-08
• 10818207025002 - Traxodent Gel FS - Bulk Syringe Kit: 2025-07-08
• 10818207025019 - Traxodent Gel FS - Value Pack: 2025-07-08
• 10818207025026 - Traxodent Gel FS - Refill Kit: 2025-07-08
• 10818207025033 - Traxodent Gel Brush Tips: 2025-07-08