33 B33225512

GUDID 03613720205845

UNiD CoCr ROD Ø5.5mm

MEDICREA INTERNATIONAL

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

Primary Device ID	03613720205845
NIH Device Record Key	b0d60838-0a32-4ff6-8af1-340426912514
Commercial Distribution Discontinuation	2021-08-18
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	33
Version Model Number	PASS LP
Catalog Number	B33225512
Company DUNS	383228632
Company Name	MEDICREA INTERNATIONAL
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	false
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	03613720205845 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K140738

FDA Product Code

MNI	Orthosis, Spinal Pedicle Fixation