Reform HA Coated Pedicle Screw 39-PH-4525

GUDID 00815362020005

Bone-screw internal spinal fixation system, sterile

Primary Device ID	00815362020005
NIH Device Record Key	80840b68-a5e1-49e7-8b48-1f1f6648a07b
Commercial Distribution Status	In Commercial Distribution
Brand Name	Reform HA Coated Pedicle Screw
Version Model Number	39-PH-4525
Catalog Number	39-PH-4525
Company DUNS	079398589
Company Name	PRECISION SPINE, INC.
Device Count	1
DM Exempt	true
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	true
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 Issuing Agency	Device ID
GS1	00815362020005 [Primary]

KWP	Appliance, Fixation, Spinal Interlaminal

Steralize Prior To Use	false
Device Is Sterile	true