MCI - MEDICAL CONCEPT INNOVATION, INC A01.02.0003

GUDID 00811687031979

AUTO DRIVE SCREW N 1.5 X 6MM

MCI-MEDICAL CONCEPT INNOVATION INC

Craniofacial bone screw, non-bioabsorbable

• Primary Device ID: 00811687031979
• NIH Device Record Key: e258d9c3-9821-45ad-80b8-3225d873cfec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MCI - MEDICAL CONCEPT INNOVATION, INC
• Version Model Number: A01.02.0003
• Catalog Number: A01.02.0003
• Company DUNS: 080815653
• Company Name: MCI-MEDICAL CONCEPT INNOVATION 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: false
• 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: 954-306-2521
• Email: customer.service@mci-medical.com
• Phone: 954-306-2521
• Email: customer.service@mci-medical.com
• Phone: 954-306-2521
• Email: customer.service@mci-medical.com
• Phone: 954-306-2521
• Email: customer.service@mci-medical.com
• Phone: 954-306-2521
• Email: customer.service@mci-medical.com
• Phone: 954-306-2521
• Email: customer.service@mci-medical.com
• Phone: 954-306-2521
• Email: customer.service@mci-medical.com
• Phone: 954-306-2521
• Email: customer.service@mci-medical.com
• Phone: 954-306-2521
• Email: customer.service@mci-medical.com
• Phone: 954-306-2521
• Email: customer.service@mci-medical.com
• Phone: 954-306-2521
• Email: customer.service@mci-medical.com
• Phone: 954-306-2521
• Email: customer.service@mci-medical.com
• Phone: 954-306-2521
• Email: customer.service@mci-medical.com
• Phone: 954-306-2521
• Email: customer.service@mci-medical.com
• Phone: 954-306-2521
• Email: customer.service@mci-medical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811687031979 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212391

FDA Product Code

• DZL: Screw, Fixation, Intraosseous

Sterilization

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

[00811687031979]

Moist Heat or Steam Sterilization

[00811687031979]

Moist Heat or Steam Sterilization

[00811687031979]

Moist Heat or Steam Sterilization

[00811687031979]

Moist Heat or Steam Sterilization

[00811687031979]

Moist Heat or Steam Sterilization

[00811687031979]

Moist Heat or Steam Sterilization

[00811687031979]

Moist Heat or Steam Sterilization

[00811687031979]

Moist Heat or Steam Sterilization

[00811687031979]

Moist Heat or Steam Sterilization

[00811687031979]

Moist Heat or Steam Sterilization

[00811687031979]

Moist Heat or Steam Sterilization

[00811687031979]

Moist Heat or Steam Sterilization

[00811687031979]

Moist Heat or Steam Sterilization

[00811687031979]

Moist Heat or Steam Sterilization

[00811687031979]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-15
• Device Publish Date: 2024-08-07

On-Brand Devices [MCI - MEDICAL CONCEPT INNOVATION, INC]

• 00811687031726: CORTICAL SCREW N 1.7 X 5MM-TI-CROSS-DRIVE
• 00811687031979: AUTO DRIVE SCREW N 1.5 X 6MM