ZIPwire™

GUDID 08714729755050

Lake Region Medical

Peripheral vascular guidewire, manual

Primary Device ID	08714729755050
NIH Device Record Key	a9706cb1-a2e4-48c4-8823-b7f3bdc20496
Commercial Distribution Status	In Commercial Distribution
Brand Name	ZIPwire™
Version Model Number	M00146350B0
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

Device Dimensions

Outer Diameter	0.035 Inch
Length	150 Centimeter
Outer Diameter	0.035 Inch
Length	150 Centimeter
Outer Diameter	0.035 Inch
Length	150 Centimeter
Outer Diameter	0.035 Inch
Length	150 Centimeter
Outer Diameter	0.035 Inch
Length	150 Centimeter
Outer Diameter	0.035 Inch
Length	150 Centimeter
Outer Diameter	0.035 Inch
Length	150 Centimeter
Outer Diameter	0.035 Inch
Length	150 Centimeter
Outer Diameter	0.035 Inch
Length	150 Centimeter
Outer Diameter	0.035 Inch
Length	150 Centimeter
Outer Diameter	0.035 Inch
Length	150 Centimeter
Outer Diameter	0.035 Inch
Length	150 Centimeter
Outer Diameter	0.035 Inch
Length	150 Centimeter
Outer Diameter	0.035 Inch
Length	150 Centimeter
Outer Diameter	0.035 Inch
Length	150 Centimeter
Outer Diameter	0.035 Inch
Length	150 Centimeter
Outer Diameter	0.035 Inch
Length	150 Centimeter
Outer Diameter	0.035 Inch
Length	150 Centimeter
Outer Diameter	0.035 Inch
Length	150 Centimeter
Outer Diameter	0.035 Inch
Length	150 Centimeter
Outer Diameter	0.035 Inch
Length	150 Centimeter
Outer Diameter	0.035 Inch
Length	150 Centimeter
Outer Diameter	0.035 Inch
Length	150 Centimeter
Outer Diameter	0.035 Inch
Length	150 Centimeter
Outer Diameter	0.035 Inch
Length	150 Centimeter
Outer Diameter	0.035 Inch
Length	150 Centimeter
Outer Diameter	0.035 Inch
Length	150 Centimeter
Outer Diameter	0.035 Inch
Length	150 Centimeter

Operating and Storage Conditions

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.
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 Identifiers

Device Issuing Agency	Device ID
GS1	08714729755050 [Package] Contains: 08714729764229 Package: [5 Units] In Commercial Distribution
GS1	08714729764229 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K000011

FDA Product Code

DQX	Wire, Guide, Catheter

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2021-12-22
Device Publish Date	2016-11-01

On-Brand Devices [ZIPwire™]

08714729770312	M00146236B0
08714729770299	M00146235B0
08714729770282	M00146232B0
08714729770268	M00146231B0
08714729755067	M00146355B0
08714729755050	M00146350B0
08714729754947	M00146331B0
08714729754930	M00146325B0
08714729754985	M00146322B0
08714729754978	M00146321B0
08714729754961	M00146319B0
08714729754954	M00146318B0
08714729754879	M00146317B0
08714729754862	M00146316B0
08714729754923	M00146315B0
08714729754916	M00146314B0
08714729754909	M00146312B0
08714729754893	M00146311B0
08714729754855	M00146309B0
08714729754848	M00146308B0
08714729754831	M00146306B0
08714729754824	M00146305B0
08714729754886	M00146301B0
08714729755043	M00146255B0
08714729755036	M00146254B0
08714729755029	M00146249B0
08714729755012	M00146240B0
08714729754800	M00146169B0
08714729754787	M00146166B0
08714729754763	M00146165B0
08714729754794	M00146164B0
08714729754770	M00146162B0
08714729754756	M00146161B0
08714729754749	M00146159B0
08714729754725	M00146156B0
08714729754701	M00146155B0
08714729754732	M00146154B0
08714729754718	M00146152B0
08714729754695	M00146151B0
08714729755005	M00146126B0
08714729754992	M00146125B0
08714729761686	M00146320B0
08714729754817	M00146300B0
08714729802501	M006630207B0
08714729839194	M006630217B0
08714729839187	M006630216B0
08714729839170	M006630215B0
08714729839163	M006630214B0
08714729839156	M006630213B0
08714729839149	M006630212B0

Trademark Results [ZIPwire]

Mark Image Registration \| Serial	Company Trademark Application Date
ZIPWIRE 88186267 not registered Dead/Abandoned	Skeletal Dynamics Inc. 2018-11-08
ZIPWIRE 86167697 not registered Dead/Abandoned	Aspect Software, Inc. 2014-01-16
ZIPWIRE 86136559 4993792 Live/Registered	Zipwire Incorporated 2013-12-05
ZIPWIRE 86136559 4993792 Live/Registered	KAP, LYNETTE ELAYNE 2013-12-05
ZIPWIRE 86122644 5013291 Live/Registered	Aspect Software, Inc. 2013-11-19
ZIPWIRE 85341385 4207265 Dead/Cancelled	Revo Brand Group, LLC 2011-06-08
ZIPWIRE 78700441 3277233 Live/Registered	Boston Scientific Scimed, Inc. 2005-08-25
ZIPWIRE 78027740 2854868 Dead/Cancelled	MINDSPEED TECHNOLOGIES, INC. 2000-09-26