AddWire™ H74922150010

GUDID 08714729315933

Cardiac/peripheral vascular guidewire, single-use

Primary Device ID	08714729315933
NIH Device Record Key	0e992f11-14bd-41ff-b1af-5e4641e686e6
Commercial Distribution Status	In Commercial Distribution
Brand Name	AddWire™
Version Model Number	H74922150010
Catalog Number	H74922150010
Company DUNS	031108704
Company Name	Lake Region Medical
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	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

Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry, dark place.

Device Issuing Agency	Device ID
GS1	08714729315933 [Primary]
GS1	08714729315940 [Package] Package: [5 Units] In Commercial Distribution

DQX	Wire, Guide, Catheter

Steralize Prior To Use	false
Device Is Sterile	true

Mark Image Registration \| Serial	Company Trademark Application Date
ADDWIRE 86423521 4747793 Live/Registered	Boston Scientific Scimed, Inc. 2014-10-14
ADDWIRE 78195853 2833337 Dead/Cancelled	BOSTON SCIENTIFIC SCIMED, INC. 2002-12-18
ADDWIRE 73458959 1345751 Dead/Cancelled	ADDITIVE TECHNOLOGY CORPORATION 1983-12-29