GTC®

GUDID M433OP1

Stereotactic radiosurgical invasive head frame

Primary Device ID	M433OP1
NIH Device Record Key	6b4ac65d-9d1a-4fa8-897f-e004133663b2
Commercial Distribution Status	In Commercial Distribution
Brand Name	GTC®
Version Model Number	OP
Company DUNS	963856096
Company Name	INTEGRA LIFESCIENCES CORPORATION
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 Issuing Agency	Device ID
GS1	10381780252825 [Primary]
HIBCC	M433OP1 [Secondary]

IYE	Accelerator, linear, medical

Steralize Prior To Use	false
Device Is Sterile	false

M433OP1	Occipital Putty
M433GTCSVS1	Velcro Strap 5/Set
M433GTCOCP1	GTC Occipital Plate (Plastic)
M433GTCDTSS1	GTC Dental Tray (Small), 5/Set
M433GTCDTSM1	GTC Dental Tray (Medium), 5/Set
M433GTCDTSL1	GTC Dental Tray (Large), 5/Set
M433GTCDPS10U1	GTC Bent Dental Plate - 10 Degrees Up (Small)
M433GTCDPS10D1	GTC Bent Dental Plate - 10 Degrees Down (Small)
M433GTCDPS1	GTC Dental Plate (Short)
M433GTCDPM10U1	GTC Bent Dental Plate - 10 Degrees UP (Medium)
M433GTCDPM10D1	GTC Bent Dental Plate - 10 Degrees Down (Medium)
M433GTCDMP1	GTC Dental Plate (Medium)
M433GTCDPL1	GTC Dental Plate (Long)
M433GTCDIMU1	GTC Dental Impression Material Upgrade
M433GTCDDU1	GTC Dental Dispenser Upgrade