StatStix

GUDID 00817051022963

StatStix Red Fine

CENTRIX, INC.

Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated Gingival retraction cord, non-medicated

• Primary Device ID: 00817051022963
• NIH Device Record Key: cbb085da-14d0-45b1-b758-1ec6a7e61861
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StatStix
• Version Model Number: 380064
• Company DUNS: 053707303
• Company Name: CENTRIX, 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817051022963 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200764

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: 2024-01-08
• Device Publish Date: 2023-12-29

On-Brand Devices [StatStix]

• 00817051022970: StatStix Black Regular
• 00817051022963: StatStix Red Fine