PASSLP

GUDID 03613720253358

ILIAC CANNULATED SCREW Ø9,5 mm x 85 mm

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

Primary Device ID	03613720253358
NIH Device Record Key	a6c1db4b-17a0-46ec-b46a-4b55b20ffadc
Commercial Distribution Status	In Commercial Distribution
Brand Name	PASSLP
Version Model Number	B22039585
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	03613720253358 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K161627

FDA Product Code

NKB	Thoracolumbosacral Pedicle Screw System