Onyx PLIF PEEK P09251100

GUDID B104P092511000

Polymeric spinal interbody fusion cage

Primary Device ID	B104P092511000
NIH Device Record Key	6c0795ff-2373-4c2c-9b36-0d1dcec94d6e
Commercial Distribution Status	In Commercial Distribution
Brand Name	Onyx PLIF PEEK
Version Model Number	P09251100
Catalog Number	P09251100
Company DUNS	066151033
Company Name	GLASIR MEDICAL LP
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	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 Size Text, specify	0
Device Size Text, specify	0

Device Issuing Agency	Device ID
HIBCC	B104P092511000 [Primary]

MAX	Intervertebral Fusion Device With Bone Graft, Lumbar

Steralize Prior To Use	true
Device Is Sterile	false

[B104P092511000]

Moist Heat or Steam Sterilization

[B104P092511000]

Moist Heat or Steam Sterilization