Prostar 12322-01

GUDID 28717648000625

PROSTAR XL10F Percutaneous Vascular Surgical System

ABBOTT VASCULAR INC.

Femoral vessel suture implantation set

• Primary Device ID: 28717648000625
• NIH Device Record Key: f471e09b-c027-4b3a-b567-d87bed435ae5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prostar
• Version Model Number: 12322-01
• Catalog Number: 12322-01
• 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
• 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 *Keep dry. Store in a cool place (room temperature).
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Store in a cool place (room temperature).
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Store in a cool place (room temperature).
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Store in a cool place (room temperature).
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Store in a cool place (room temperature).
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Store in a cool place (room temperature).
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Store in a cool place (room temperature).
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Store in a cool place (room temperature).
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Store in a cool place (room temperature).
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Store in a cool place (room temperature).
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Store in a cool place (room temperature).
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Store in a cool place (room temperature).
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Store in a cool place (room temperature).
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Store in a cool place (room temperature).
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Store in a cool place (room temperature).
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Store in a cool place (room temperature).
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Store in a cool place (room temperature).
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Store in a cool place (room temperature).
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Store in a cool place (room temperature).
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Store in a cool place (room temperature).
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Store in a cool place (room temperature).
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Store in a cool place (room temperature).
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Store in a cool place (room temperature).
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Store in a cool place (room temperature).
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Store in a cool place (room temperature).

Device Identifiers

Device Issuing Agency	Device ID
GS1	08717648000621 [Primary]
GS1	28717648000625 [Package]; Contains: 08717648000621; Package: Case [5 Units]; In Commercial Distribution

FDA Product Code

• MGB: DEVICE, HEMOSTASIS, VASCULAR

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: 2021-02-19
• Device Publish Date: 2014-11-21

Devices Manufactured by ABBOTT VASCULAR INC.

• 08717648353765 - Esprit™: 2025-07-21 Esprit™ BTK Everolimus Eluting Resorbable Scaffold System 3.75mm x 28mm Over-The-Wire
• 08717648353666 - Esprit™: 2025-07-18 Esprit™ BTK Everolimus Eluting Resorbable Scaffold System 3.50mm x 18mm Over-The-Wire
• 08717648353680 - Esprit™: 2025-07-18 Esprit™ BTK Everolimus Eluting Resorbable Scaffold System 3.50mm x 28mm Over-The-Wire
• 08717648353703 - Esprit™: 2025-07-18 Esprit™ BTK Everolimus Eluting Resorbable Scaffold System 3.50mm x 38mm Over-The-Wire
• 08717648353741 - Esprit™: 2025-07-18 Esprit™ BTK Everolimus Eluting Resorbable Scaffold System 3.75mm x 18mm Over-The-Wire
• 08717648353789 - Esprit™: 2025-07-18 Esprit™ BTK Everolimus Eluting Resorbable Scaffold System 3.75mm x 38mm Over-The-Wire
• 08717648353826 - Esprit™: 2025-07-18 Esprit™ BTK Everolimus Eluting Resorbable Scaffold System 2.50mm x 18mm Over-The-Wire
• 08717648353840 - Esprit™: 2025-07-18 Esprit™ BTK Everolimus Eluting Resorbable Scaffold System 2.50mm x 28mm Over-The-Wire