Retrax Pellets 12400

GUDID 00310866000800

Hemostatic cotton pellets with aluminum sulfate

PASCAL COMPANY, INC.

Gingival retraction cord, medicated

• Primary Device ID: 00310866000800
• NIH Device Record Key: e9d76b63-20da-499c-a73a-0fad20f4c6b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Retrax Pellets
• Version Model Number: 12400
• Catalog Number: 12400
• Company DUNS: 009260217
• Company Name: PASCAL COMPANY, INC.
• Device Count: 350
• 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: 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: 8004268051
• Email: pascal@pascaldental.com
• Phone: 8004268051
• Email: pascal@pascaldental.com
• Phone: 8004268051
• Email: pascal@pascaldental.com
• Phone: 8004268051
• Email: pascal@pascaldental.com
• Phone: 8004268051
• Email: pascal@pascaldental.com
• Phone: 8004268051
• Email: pascal@pascaldental.com
• Phone: 8004268051
• Email: pascal@pascaldental.com
• Phone: 8004268051
• Email: pascal@pascaldental.com
• Phone: 8004268051
• Email: pascal@pascaldental.com
• Phone: 8004268051
• Email: pascal@pascaldental.com
• Phone: 8004268051
• Email: pascal@pascaldental.com
• Phone: 8004268051
• Email: pascal@pascaldental.com
• Phone: 8004268051
• Email: pascal@pascaldental.com
• Phone: 8004268051
• Email: pascal@pascaldental.com
• Phone: 8004268051
• Email: pascal@pascaldental.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00310866000800 [Primary]
GS1	00310866002019 [Unit of Use]

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: 2019-03-04
• Device Publish Date: 2019-01-31

Devices Manufactured by PASCAL COMPANY, INC.

• 00310866002552 - KOIS KR-1 PACKER: 2024-06-12 RETRACTION CORD PACKING INSTRUMENT INSPIRED BY KOIS 0.5MM HEAD
• 00310866002606 - KOIS KR-2 PACKER: 2024-06-12 RETRACTION CORD PACKING INSTRUMENT INSPIRED BY KOIS 1MM HEAD
• 00310866002613 - KOIS KR-3 PACKER: 2024-06-12 RETRACTION CORD PACKER INSPIRED BY KOIS 1.5MM HEAD
• 00310866002620 - KOIS KR-4 PACKER: 2024-06-12 RETRACTION CORD PACKER INSPIRED BY KOIS 2MM HEAD
• 00310866002637 - KOIS KR-5 PACKER: 2024-06-12 RETRACTION CORD PACKER INSPIRED BY KOIS 2.5MM HEAD
• 00310866002644 - GET SCULPTED: 2024-05-24 Wax Carving Set
• 00310866002651 - Fluorilaq Salted Caramel (10mL) Tube: 2024-04-05 5% Sodium Fluoride with Xylitol. No separation, no mixing & no mess. Ideal for hypersensitivity treatments.
• 00310866002668 - Fluorilaq Mint (10mL) Tube: 2024-04-05 5% Fluoride Varnish with Xylitol. Ideal for cavity varnish.