Xact™ 83021-01

GUDID 08717648356759

Xact™ Transcarotid Stent System 7.0 mm x 30 mm Straight

ABBOTT VASCULAR INC.

Bare-metal carotid artery stent

• Primary Device ID: 08717648356759
• NIH Device Record Key: 48d98dac-d5d9-4095-b69a-dfe1e7e48072
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xact™
• Version Model Number: 83021-01
• Catalog Number: 83021-01
• Company DUNS: 964569052
• Company Name: ABBOTT VASCULAR INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Do not expose to organic solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Do not expose to organic solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Do not expose to organic solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Do not expose to organic solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Do not expose to organic solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Do not expose to organic solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Do not expose to organic solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Do not expose to organic solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Do not expose to organic solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Do not expose to organic solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Do not expose to organic solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Do not expose to organic solvents or ionizing radiation.

Device Identifiers

Device Issuing Agency	Device ID
GS1	08717648356759 [Primary]

FDA Product Code

• NIM: STENT, CAROTID

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-28
• Device Publish Date: 2024-10-18

On-Brand Devices [Xact™ ]

• 08717648356797: Xact™ Transcarotid Stent System 10.0 mm x 30 mm Straight
• 08717648356780: Xact™ Transcarotid Stent System 10.0 mm x 30 mm Tapered
• 08717648356773: Xact™ Transcarotid Stent System 10.0 mm x 40 mm Tapered
• 08717648356759: Xact™ Transcarotid Stent System 7.0 mm x 30 mm Straight
• 08717648356735: Xact™ Transcarotid Stent System 8.0 mm x 30 mm Straight
• 08717648356728: Xact™ Transcarotid Stent System 8.0 mm x 30 mm Tapered
• 08717648356711: Xact™ Transcarotid Stent System 8.0 mm x 40 mm Tapered
• 08717648356698: Xact™ Transcarotid Stent System 9.0 mm x 30 mm Straight
• 08717648356681: Xact™ Transcarotid Stent System 9.0 mm x 30 mm Tapered
• 08717648356674: Xact™ Transcarotid Stent System 9.0 mm x 40 mm Tapered