Galeo Pro 389781

GUDID 00814384020192

Cardiac/peripheral vascular guidewire, single-use

Primary Device ID	00814384020192
NIH Device Record Key	6048faf3-b814-425a-b99c-709ae647db21
Commercial Distribution Status	In Commercial Distribution
Brand Name	Galeo Pro
Version Model Number	HF
Catalog Number	389781
Company DUNS	189689800
Company Name	CONCERT MEDICAL, LLC
Device Count	5
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	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Storage Environment Temperature	Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Issuing Agency	Device ID
GS1	00814384020185 [Unit of Use]
GS1	00814384020192 [Primary]

DQX	Wire, Guide, Catheter

Steralize Prior To Use	false
Device Is Sterile	true