UroWire® Guidewire with SL-6® Hydrophilic Coating

GUDID 10607915113855

General-purpose non-vascular guidewire General-purpose non-vascular guidewire General-purpose non-vascular guidewire

Primary Device ID	10607915113855
NIH Device Record Key	e76a4bb0-6e4b-49cd-aec5-af408e188d28
Commercial Distribution Status	In Commercial Distribution
Brand Name	UroWire® Guidewire with SL-6® Hydrophilic Coating
Version Model Number	B8634
Company DUNS	187129135
Company Name	APPLIED MEDICAL RESOURCES 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	true
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00607915113858 [Primary]
GS1	10607915113855 [Package] Contains: 00607915113858 Package: [6 Units] In Commercial Distribution

KNY	Accessories, Catheter, G-U

Steralize Prior To Use	false
Device Is Sterile	true

10607915113855	Urological Guidewire
10607915113831	B8134

Mark Image Registration \| Serial	Company Trademark Application Date
UROWIRE 76478746 2870277 Live/Registered	APPLIED MEDICAL RESOURCES CORPORATION 2002-12-18