Prostar 12322-01

GUDID 28717648000625

PROSTAR XL10F Percutaneous Vascular Surgical System

ABBOTT VASCULAR INC.

Femoral vessel suture implantation set Femoral vessel suture implantation set Femoral vessel suture implantation set Femoral vessel suture implantation set Femoral vessel suture implantation set Femoral vessel suture implantation set Femoral vessel suture implantation set Femoral vessel suture implantation set Femoral vessel suture implantation set Femoral vessel suture implantation set Femoral vessel suture implantation set Femoral vessel suture implantation set Femoral vessel suture implantation set Femoral vessel suture implantation set Femoral vessel suture implantation set 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

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).

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.

• 28717648013427 - HI-TORQUE BALANCE: 2024-03-25 HI-TORQUE BALANCE Guide Wire .014 Straight Tip 3.0 cm x 190 cm
• 28717648013434 - HI-TORQUE BALANCE: 2024-03-25 HI-TORQUE BALANCE Guide Wire .014 Straight Tip 3.0 cm x 300 cm
• 28717648014332 - HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL: 2024-03-25 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL Guide Wire .014 Straight Tip 3.0 cm x 190 cm
• 28717648014349 - HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL: 2024-03-25 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL Guide Wire .014 Straight Tip 3.0 cm x 300 cm
• 28717648014356 - HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL: 2024-03-25 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL Guide Wire .014 StraightTip w/o marker 190 cm
• 08717648014369 - HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL: 2024-03-25 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL Guide Wire .014 Straight Tip w/o marker 300 cm
• 08717648015489 - HI-TORQUE BALANCE HEAVYWEIGHT: 2024-03-25 HI-TORQUE BALANCE HEAVYWEIGHT Guide Wire w/Hydrocoat .014 Straight 4.5 cm x 190 cm
• 08717648015496 - HI-TORQUE BALANCE HEAVYWEIGHT: 2024-03-25 HI-TORQUE BALANCE HEAVYWEIGHT Guide Wire w/Hydrocoat .014 J Tip 4.5 cm x 190 cm