HI-TORQUE STANDARD 22318H

GUDID 28717648079911

HI-TORQUE STANDARD Guide Wire w/Hydrocoat .014 Straight Tip 2.0 cm x 190 cm

ABBOTT VASCULAR INC.

Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 28717648079911
• NIH Device Record Key: 04773ddc-ad7e-4004-b0fe-81114bf11b11
• Commercial Distribution Discontinuation: 2021-01-17
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: HI-TORQUE STANDARD
• Version Model Number: 22318H
• Catalog Number: 22318H
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08717648079917 [Primary]
GS1	28717648079911 [Package]; Contains: 08717648079917; Package: Case [5 Units]; Discontinued: 2021-01-17; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K974773

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: 2024-02-07
• Device Publish Date: 2016-02-12

On-Brand Devices [HI-TORQUE STANDARD]

• 28717648080030: HI-TORQUE STANDARD Guide Wire .014 Straight Tip 2.0 cm x 300 cm
• 08717648080029: HI-TORQUE STANDARD Guide Wire w/Hydrocoat .014 Straight Tip 2.0 cm x 300 cm
• 28717648079980: HI-TORQUE STANDARD Guide Wire with MICROGLIDE Coating .014 Straight Tip 2.0 cm x 300 cm
• 08717648079962: HI-TORQUESTANDARD Guide Wire .014 Straight Tip 2.0 cm x 190 cm
• 08717648079955: HI-TORQUE STANDARD Guide Wire w/Hydrocoat .014 J Tip 30 cm x 190 cm
• 28717648079942: HI-TORQUE STANDARD Guide Wire w/Hydrocoat .014 J Tip 2.0 cm x 190 cm
• 28717648079935: HI-TORQUE STANDARD Guide Wire w/Hydrocoat .014 Straight Tip 30 cm x 190 cm
• 28717648079911: HI-TORQUE STANDARD Guide Wire w/Hydrocoat .014 Straight Tip 2.0 cm x 190 cm