Acculink 1011337-30

GUDID 08717648076190

RX ACCULINK Carotid Stent System 5.0 mm x 30 mm x 132 cm Rapid-Exchange

ABBOTT VASCULAR INC.

Bare-metal carotid artery stent

• Primary Device ID: 08717648076190
• NIH Device Record Key: e35d47e4-517a-41ae-bea4-5f9ee22671c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acculink
• Version Model Number: 1011337-30
• Catalog Number: 1011337-30
• 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

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: john3103@gmail.com
• Phone: +1(800)227-9902
• Email: john3103@gmail.com
• Phone: +1(800)227-9902
• Email: john3103@gmail.com
• Phone: +1(800)227-9902
• Email: john3103@gmail.com
• Phone: +1(800)227-9902
• Email: john3103@gmail.com
• Phone: +1(800)227-9902
• Email: john3103@gmail.com
• Phone: +1(800)227-9902
• Email: john3103@gmail.com
• Phone: +1(800)227-9902
• Email: john3103@gmail.com
• Phone: +1(800)227-9902
• Email: john3103@gmail.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, cool place. The temperature of the stent system must not exceed 55 degrees C.
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, cool place. The temperature of the stent system must not exceed 55 degrees C.
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, cool place. The temperature of the stent system must not exceed 55 degrees C.
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, cool place. The temperature of the stent system must not exceed 55 degrees C.
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, cool place. The temperature of the stent system must not exceed 55 degrees C.
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, cool place. The temperature of the stent system must not exceed 55 degrees C.
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, cool place. The temperature of the stent system must not exceed 55 degrees C.
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, cool place. The temperature of the stent system must not exceed 55 degrees C.
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, cool place. The temperature of the stent system must not exceed 55 degrees C.
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, cool place. The temperature of the stent system must not exceed 55 degrees C.
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, cool place. The temperature of the stent system must not exceed 55 degrees C.
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, cool place. The temperature of the stent system must not exceed 55 degrees C.
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, cool place. The temperature of the stent system must not exceed 55 degrees C.
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, cool place. The temperature of the stent system must not exceed 55 degrees C.
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, cool place. The temperature of the stent system must not exceed 55 degrees C.
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, cool place. The temperature of the stent system must not exceed 55 degrees C.
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, cool place. The temperature of the stent system must not exceed 55 degrees C.
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, dark, cool place. The temperature of the stent system must not exceed 55 degrees C.
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08717648076190 [Primary]

FDA Product Code

• NIM: STENT, CAROTID

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-02-05
• Device Publish Date: 2014-11-21

On-Brand Devices [Acculink]

• 08717648076398: RX ACCULINK Carotid Stent System 7-10 mm x 40 mm x 132 cm Rapid-Exchange
• 08717648076381: RX ACCULINK Carotid Stent System 7-10 mm x 30 mm x 132 cm Rapid-Exchange
• 08717648076374: RX ACCULINK Carotid Stent System 6-8 mm x 40 mm x 132 cm Rapid-Exchange
• 08717648076367: RX ACCULINK Carotid Stent System 6-8 mm x 30 mm x 132 cm Rapid-Exchange
• 08717648076350: RX ACCULINK Carotid Stent System 10 mm x 40 mm x 132 cm Rapid-Exchange
• 08717648076343: RX ACCULINK Carotid Stent System 10mm x 30 mm x 132 cm Rapid-Exchange
• 08717648076336: RX ACCULINK Carotid Stent System 10 mm x 20 mm x 132 cm Rapid-Exchange
• 08717648076329: RX ACCULINK Carotid Stent System 9.0 mm x 40 mm x 132cm Rapid-Exchange
• 08717648076312: RX ACCULINK Carotid Stent System 9.0 mm x 30 mm x 132 cm Rapid-Exchange
• 08717648076305: RX ACCULINK CarotidStent System 9.0 mm x 20 mm x 132 cm Rapid-Exchange
• 08717648076299: RX ACCULINK Carotid Stent System 8.0 mm x 40 mm x 132 cm Rapid-Exchange
• 08717648076282: RX ACCULINK Carotid Stent System 8.0 mm x 30 mm x 132 cm Rapid-Exchange
• 08717648076275: RX ACCULINK Carotid Stent System 8.0 mm x 20 mm x 132 cm Rapid-Exchange
• 08717648076268: RX ACCULINK Carotid Stent System 7.0 mm x 40 mm x 132 cm Rapid-Exchange
• 08717648076251: RX ACCULINK Carotid Stent System 7.0 mm x 30 mm x 132 cm Rapid-Exchange
• 08717648076244: RX ACCULINK Carotid Stent System 7.0 mm x 20 mm x 132 cm Rapid-Exchange
• 08717648076237: RX ACCULINK Carotid Stent System 6.0 mm x 40 mm x 132 cm Rapid-Exchange
• 08717648076220: RX ACCULINK Carotid Stent System 6.0 mm x 30 mm x 132 cm Rapid-Exchange
• 08717648076213: RX ACCULINK Carotid Stent System 6.0 mm x 20 mm x 132 cm Rapid-Exchange
• 08717648076206: RX ACCULINK Carotid Stent System 5.0 mm x 40 mm x 132 cm Rapid-Exchange
• 08717648076190: RX ACCULINK Carotid Stent System 5.0 mm x 30 mm x 132 cm Rapid-Exchange
• 08717648076183: RX ACCULINK Carotid Stent System 5.0 mm x 20 mm x 132 cm Rapid-Exchange