TriPhasix™ S400

GUDID 30810000526155

1lb. TriPhasix™ Chromatic Alginate

PARKELL, INC.

Alginate dental impression material

• Primary Device ID: 30810000526155
• NIH Device Record Key: 7fb81065-1553-439c-8b50-34f5e820e63e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TriPhasix™
• Version Model Number: S400
• Catalog Number: S400
• Company DUNS: 009900424
• Company Name: PARKELL, 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: 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: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep container tightly closed and store in a cool, dry and well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Keep container tightly closed and store in a cool, dry and well-ventilated place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810000526154 [Primary]
GS1	10810000526151 [Package]; Contains: 00810000526154; Package: Box [5 Units]; In Commercial Distribution
GS1	20810000526158 [Package]; Contains: 00810000526154; Package: Box [10 Units]; In Commercial Distribution
GS1	30810000526155 [Package]; Contains: 00810000526154; Package: Box [25 Units]; In Commercial Distribution

FDA Product Code

• ELW: Material, Impression

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: 2018-12-24
• Device Publish Date: 2018-11-23

On-Brand Devices [TriPhasix™]

• 30810000526155: 1lb. TriPhasix™ Chromatic Alginate
• M595S4043: 1lb. TriPhasix™ Chromatic Alginate
• 10810000526182: Measuring Scoops TriPhasix™ Alginate (2 each)
• 00810000528271: Measuring Scoops TriPhasix™ Alginate