FAS-TRACT

GUDID 00366975013347

FAS-TRACT 25% Clear Aluminum Chloride Gel Kit

BENCO DENTAL SUPPLY CO.

Multiple coagulation factor IVD, reagent

• Primary Device ID: 00366975013347
• NIH Device Record Key: d80e43db-8d4e-4eb7-adfe-5725d8845dfd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FAS-TRACT
• Version Model Number: 4006-906
• Company DUNS: 015108087
• Company Name: BENCO DENTAL SUPPLY CO.
• 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

Customer Support Contacts

• Phone: 570-602-6924
• Email: jsoroka@benco.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00366975013347 [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: 2019-01-07
• Device Publish Date: 2018-12-05

On-Brand Devices [FAS-TRACT]

• 00366975013408: FAS-TRACT Epinephrine #0 Knitted Retraction Cord 100 inches
• 00366975013392: FAS-TRACT Epinepherine #00 Knitted Retraction Cord 100 inches
• 00366975013385: FAS-TRACT #2 Retraction Cord Plain 100 inches
• 00366975013378: FAS-TRACT #1 Retraction Cord Plain 100 inches
• 00366975013361: FAS-TRACT #0 Retraction Cord Plain 100 inches
• 00366975013354: FAS-TRACT #00 Retraction Cord Plain 100 inches
• 00366975013347: FAS-TRACT 25% Clear Aluminum Chloride Gel Kit