Pedicle Screw

GUDID B014IPSSC100

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

Primary Device ID	B014IPSSC100
NIH Device Record Key	b28b7984-1569-44a2-96a9-c43329b51955
Commercial Distribution Status	In Commercial Distribution
Brand Name	Pedicle Screw
Version Model Number	IPSSC100
Company DUNS	022576742
Company Name	EMINENT SPINE LLC
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

Device Issuing Agency	Device ID
HIBCC	B014IPSSC100 [Primary]

MNI	Orthosis, Spinal Pedicle Fixation

Steralize Prior To Use	true
Device Is Sterile	false

[B014IPSSC100]

Moist Heat or Steam Sterilization

[B014IPSSC100]

Moist Heat or Steam Sterilization