HI-TORQUE EXTRA S'PORT 22225MJ

GUDID 28717648079591

HI-TORQUE EXTRA S'PORT Guide Wire .014 J Tip 3.0 cm x 190 cm

ABBOTT VASCULAR INC.

Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 28717648079591
• NIH Device Record Key: d25d9ed8-1412-4cb5-bf26-e99b853aff00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HI-TORQUE EXTRA S'PORT
• Version Model Number: 22225MJ
• Catalog Number: 22225MJ
• Company DUNS: 964569052
• Company Name: ABBOTT VASCULAR INC.
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)227-9902
• Email: AV.CUSTOMERCARE@AV.ABBOTT.COM
• Phone: +1(800)227-9902
• Email: AV.CUSTOMERCARE@AV.ABBOTT.COM
• Phone: +1(800)227-9902
• Email: AV.CUSTOMERCARE@AV.ABBOTT.COM
• Phone: +1(800)227-9902
• Email: AV.CUSTOMERCARE@AV.ABBOTT.COM
• Phone: +1(800)227-9902
• Email: AV.CUSTOMERCARE@AV.ABBOTT.COM
• Phone: +1(800)227-9902
• Email: AV.CUSTOMERCARE@AV.ABBOTT.COM
• Phone: +1(800)227-9902
• Email: AV.CUSTOMERCARE@AV.ABBOTT.COM
• Phone: +1(800)227-9902
• Email: AV.CUSTOMERCARE@AV.ABBOTT.COM
• Phone: +1(800)227-9902
• Email: AV.CUSTOMERCARE@AV.ABBOTT.COM
• Phone: +1(800)227-9902
• Email: AV.CUSTOMERCARE@AV.ABBOTT.COM
• Phone: +1(800)227-9902
• Email: AV.CUSTOMERCARE@AV.ABBOTT.COM
• Phone: +1(800)227-9902
• Email: AV.CUSTOMERCARE@AV.ABBOTT.COM
• Phone: +1(800)227-9902
• Email: AV.CUSTOMERCARE@AV.ABBOTT.COM
• Phone: +1(800)227-9902
• Email: AV.CUSTOMERCARE@AV.ABBOTT.COM
• Phone: +1(800)227-9902
• Email: AV.CUSTOMERCARE@AV.ABBOTT.COM
• Phone: +1(800)227-9902
• Email: AV.CUSTOMERCARE@AV.ABBOTT.COM
• Phone: +1(800)227-9902
• Email: AV.CUSTOMERCARE@AV.ABBOTT.COM
• Phone: +1(800)227-9902
• Email: AV.CUSTOMERCARE@AV.ABBOTT.COM

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry, dark, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry, dark, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry, dark, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry, dark, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry, dark, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry, dark, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry, dark, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry, dark, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry, dark, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry, dark, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry, dark, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry, dark, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry, dark, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry, dark, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry, dark, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry, dark, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry, dark, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry, dark, cool place

Device Identifiers

Device Issuing Agency	Device ID
GS1	08717648079597 [Primary]
GS1	28717648079591 [Package]; Contains: 08717648079597; Package: Case [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K950156

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: 5
• Public Version Date: 2020-03-23
• Device Publish Date: 2016-02-19