Mark II

GUDID 00817051021911

Mark II Snap Fit Kit

CENTRIX, INC.

Dental material cartridge-plunging applicator, single-component Dental material cartridge-plunging applicator, single-component Dental material cartridge-plunging applicator, single-component Dental material cartridge-plunging applicator, single-component Dental material cartridge-plunging applicator, single-component Dental material cartridge-plunging applicator, single-component Dental material cartridge-plunging applicator, single-component Dental material cartridge-plunging applicator, single-component Dental material cartridge-plunging applicator, single-component Dental material cartridge-plunging applicator, single-component Dental material cartridge-plunging applicator, single-component Dental material cartridge-plunging applicator, single-component Dental material cartridge-plunging applicator, single-component Dental material cartridge-plunging applicator, single-component Dental material cartridge-plunging applicator, single-component Dental material cartridge-plunging applicator, single-component Dental material cartridge-plunging applicator, single-component

• Primary Device ID: 00817051021911
• NIH Device Record Key: 189f4501-e10f-40e8-b0e9-77b96492ce65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mark II
• Version Model Number: 140615
• Company DUNS: 053707303
• Company Name: CENTRIX, INC.
• Device Count: 1
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	00817051021911 [Primary]

FDA Product Code

• EID: Syringe, Restorative And Impression Material

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 [Mark II]

• 00817051023748: Mark II Snap Fit Syringe
• 00817051021911: Mark II Snap Fit Kit