ZIPwire™

GUDID 08714729770312

Lake Region Medical

Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual

• Primary Device ID: 08714729770312
• NIH Device Record Key: 972888ad-e3b5-4ca4-8a3e-ed166b66d68f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZIPwire™
• Version Model Number: M00146236B0
• 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: 0.018 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 180 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 180 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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729765165 [Primary]
GS1	08714729770312 [Package]; Contains: 08714729765165; Package: [5 Units]; In Commercial Distribution

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