ABSORB GT1 1235250-12

GUDID 08717648212949

Absorb GT1 Bioresorbable Vascular Scaffold System 2.50 mm x 12 mm / Rapid-Exchange

ABBOTT VASCULAR INC.

Drug-eluting coronary artery stent, fully-bioabsorbable Drug-eluting coronary artery stent, fully-bioabsorbable Drug-eluting coronary artery stent, fully-bioabsorbable Drug-eluting coronary artery stent, fully-bioabsorbable Drug-eluting coronary artery stent, fully-bioabsorbable Drug-eluting coronary artery stent, fully-bioabsorbable Drug-eluting coronary artery stent, fully-bioabsorbable Drug-eluting coronary artery stent, fully-bioabsorbable Drug-eluting coronary artery stent, fully-bioabsorbable Drug-eluting coronary artery stent, fully-bioabsorbable Drug-eluting coronary artery stent, fully-bioabsorbable Drug-eluting coronary artery stent, fully-bioabsorbable Drug-eluting coronary artery stent, fully-bioabsorbable Drug-eluting coronary artery stent, fully-bioabsorbable Drug-eluting coronary artery stent, fully-bioabsorbable Drug-eluting coronary artery stent, fully-bioabsorbable

• Primary Device ID: 08717648212949
• NIH Device Record Key: 342cddc2-16a3-4525-92f2-66ed25c1cec3
• Commercial Distribution Discontinuation: 2019-03-14
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ABSORB GT1
• Version Model Number: 1235250-12
• Catalog Number: 1235250-12
• 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: true
• 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

• Handling Environment Temperature: Between -20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at or below 25 degrees C; excursions permitted to 30 degrees C. Check temperature indicator prior to use of product.
• Handling Environment Temperature: Between -20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at or below 25 degrees C; excursions permitted to 30 degrees C. Check temperature indicator prior to use of product.
• Handling Environment Temperature: Between -20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at or below 25 degrees C; excursions permitted to 30 degrees C. Check temperature indicator prior to use of product.
• Handling Environment Temperature: Between -20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at or below 25 degrees C; excursions permitted to 30 degrees C. Check temperature indicator prior to use of product.
• Handling Environment Temperature: Between -20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at or below 25 degrees C; excursions permitted to 30 degrees C. Check temperature indicator prior to use of product.
• Handling Environment Temperature: Between -20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at or below 25 degrees C; excursions permitted to 30 degrees C. Check temperature indicator prior to use of product.
• Handling Environment Temperature: Between -20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at or below 25 degrees C; excursions permitted to 30 degrees C. Check temperature indicator prior to use of product.
• Handling Environment Temperature: Between -20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at or below 25 degrees C; excursions permitted to 30 degrees C. Check temperature indicator prior to use of product.
• Handling Environment Temperature: Between -20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at or below 25 degrees C; excursions permitted to 30 degrees C. Check temperature indicator prior to use of product.
• Handling Environment Temperature: Between -20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at or below 25 degrees C; excursions permitted to 30 degrees C. Check temperature indicator prior to use of product.
• Handling Environment Temperature: Between -20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at or below 25 degrees C; excursions permitted to 30 degrees C. Check temperature indicator prior to use of product.
• Handling Environment Temperature: Between -20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at or below 25 degrees C; excursions permitted to 30 degrees C. Check temperature indicator prior to use of product.
• Handling Environment Temperature: Between -20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at or below 25 degrees C; excursions permitted to 30 degrees C. Check temperature indicator prior to use of product.
• Handling Environment Temperature: Between -20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at or below 25 degrees C; excursions permitted to 30 degrees C. Check temperature indicator prior to use of product.
• Handling Environment Temperature: Between -20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at or below 25 degrees C; excursions permitted to 30 degrees C. Check temperature indicator prior to use of product.
• Handling Environment Temperature: Between -20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at or below 25 degrees C; excursions permitted to 30 degrees C. Check temperature indicator prior to use of product.

Device Identifiers

Device Issuing Agency	Device ID
GS1	08717648212949 [Primary]

FDA Product Code

• PNY: Absorbable coronary drug-eluting stent

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: 2021-02-05
• Device Publish Date: 2016-07-15

On-Brand Devices [ABSORB GT1]

• 08717648213144: Absorb GT1 Bioresorbable Vascular Scaffold System 3.50 mm x 28 mm / Rapid-Exchange
• 08717648213137: Absorb GT1 Bioresorbable Vascular Scaffold System 3.50 mm x 23 mm / Rapid-Exchange
• 08717648213120: Absorb GT1 Bioresorbable Vascular Scaffold System 3.50 mm x 18 mm / Rapid-Exchange
• 08717648213106: Absorb GT1 Bioresorbable Vascular Scaffold System 3.50 mm x 12 mm / Rapid-Exchange
• 08717648213069: Absorb GT1 Bioresorbable Vascular Scaffold System 3.00 mm x 28 mm / Rapid-Exchange
• 08717648213052: Absorb GT1 Bioresorbable Vascular Scaffold System 3.00 mm x 23 mm / Rapid-Exchange
• 08717648213045: Absorb GT1 Bioresorbable Vascular Scaffold System 3.00 mm x 18 mm / Rapid-Exchange
• 08717648213021: Absorb GT1 Bioresorbable Vascular Scaffold System 3.00 mm x 12 mm / Rapid-Exchange
• 08717648213014: Absorb GT1 Bioresorbable Vascular Scaffold System 3.00 mm x 8 mm / Rapid-Exchange
• 08717648212987: Absorb GT1 Bioresorbable Vascular Scaffold System 2.50 mm x 28 mm / Rapid-Exchange
• 08717648212970: Absorb GT1 Bioresorbable Vascular Scaffold System 2.50 mm x 23 mm / Rapid-Exchange
• 08717648212963: Absorb GT1 Bioresorbable Vascular Scaffold System 2.50 mm x 18 mm / Rapid-Exchange
• 08717648212949: Absorb GT1 Bioresorbable Vascular Scaffold System 2.50 mm x 12 mm / Rapid-Exchange
• 08717648212932: Absorb GT1 Bioresorbable Vascular Scaffold System 2.50 mm x 8 mm / Rapid-Exchange