MCI - Medical Concept Innovation, Inc A01.02.0005

GUDID 00811687031726

CORTICAL SCREW N 1.7 X 5MM-TI-CROSS-DRIVE

MCI-MEDICAL CONCEPT INNOVATION INC

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

Primary Device ID	00811687031726
NIH Device Record Key	de845a09-1d0b-41ab-ae73-a8c7d2d2cca9
Commercial Distribution Status	In Commercial Distribution
Brand Name	MCI - Medical Concept Innovation, Inc
Version Model Number	A01.02.0005
Catalog Number	A01.02.0005
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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811687031726 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K182758

FDA Product Code

DZL	Screw, Fixation, Intraosseous