Calciject

GUDID 00817051020822

Calciject prefilled Calcium Hydroxide paste tips, 24

CENTRIX, INC.

Calcium hydroxide suspension Calcium hydroxide suspension Calcium hydroxide suspension

• Primary Device ID: 00817051020822
• NIH Device Record Key: 20119ddf-ec3b-4483-9afa-256b6fbb938b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Calciject
• Version Model Number: 320003
• 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	00817051020822 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001050

FDA Product Code

• EJK: Liner, Cavity, Calcium Hydroxide

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

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