ViscoStat Clear 6409

GUDID 00883205035653

ViscoStat Clear Dento-Infusor Kit

ULTRADENT PRODUCTS, INC.

Gingival retraction solution

• Primary Device ID: 00883205035653
• NIH Device Record Key: 5c572fe9-1955-482a-87aa-0ccc2af01c9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ViscoStat Clear
• Version Model Number: 6409
• Catalog Number: 6409
• Company DUNS: 013369913
• Company Name: ULTRADENT PRODUCTS, INC.
• 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: true
• 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

Customer Support Contacts

• Phone: 801-572-4200
• Email: customerservice@ultradent.com
• Phone: 801-572-4200
• Email: customerservice@ultradent.com
• Phone: 801-572-4200
• Email: customerservice@ultradent.com
• Phone: 801-572-4200
• Email: customerservice@ultradent.com
• Phone: 801-572-4200
• Email: customerservice@ultradent.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 18 Degrees Celsius and 29 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 29 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 29 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 29 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 29 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883205035653 [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: 2022-11-16
• Device Publish Date: 2022-11-08

On-Brand Devices [ViscoStat Clear]

• 00883205106896: ViscoStat Clear IndiSpense Refill
• 00883205106889: ViscoStat Clear Dento-Infusor Indispense Kit
• 00883205103208: ViscoStat Clear Dento-Infusor Kit
• 00883205103192: ViscoStat Clear Econo Refill
• 00883205004550: VISCOSTAT CLEAR SAMPLE
• 00883205035707: ViscoStat Clear Sample
• 00883205035653: ViscoStat Clear Dento-Infusor Kit
• 00883205035646: ViscoStat Clear Dento-Infusor Indispense Kit