EU Retrax Gel AS Clear ProPack 16840

GUDID 00310866002330

25% aluminum sulfate gel, 12 - 0.75g syringe; no color

PASCAL COMPANY, INC.

Gingival retraction solution

• Primary Device ID: 00310866002330
• NIH Device Record Key: 89620e03-e658-46e3-b934-8d80f5af4ca4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EU Retrax Gel AS Clear ProPack
• Version Model Number: 16840
• Catalog Number: 16840
• Company DUNS: 009260217
• Company Name: PASCAL COMPANY, INC.
• Device Count: 12
• 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

Device Dimensions

• Weight: 0.75 Gram
• Weight: 0.75 Gram
• Weight: 0.75 Gram
• Weight: 0.75 Gram
• Weight: 0.75 Gram
• Weight: 0.75 Gram
• Weight: 0.75 Gram
• Weight: 0.75 Gram

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00310866001715 [Unit of Use]
GS1	00310866002330 [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: 2022-07-01
• Device Publish Date: 2022-06-23

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.