ABSORB GT1

Basic Information

• Brand Name: ABSORB GT1
• Primary DI: 08717648213014
• Version / Model: 1235300-08
• Catalog Number: 1235300-08
• Company Name: ABBOTT VASCULAR INC.
• Labeler DUNS: 964569052
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-15
• Public Version: 4
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: 522e0435-9d74-4149-a1f1-a3cfc9815868
• Distribution End Date: 2019-03-14

Device Description

Absorb GT1 Bioresorbable Vascular Scaffold System 3.00 mm x 8 mm / Rapid-Exchange

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PNY	Absorbable coronary drug-eluting stent	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
56304	Drug-eluting coronary artery stent, fully-bioabsorbable	A bioabsorbable tubular or coil-shaped device with a drug coating intended to be implanted, via a delivery catheter, into a de novo or restenotic native coronary artery during a percutaneous coronary intervention (PCI) to temporarily maintain its patency, typically in patients with symptomatic atherosclerotic heart disease. The drug coating is intended to inhibit restenosis by reducing vessel smooth muscle cell proliferation. The device is made of a material capable of being degraded and absorbed by body tissues (e.g., bioabsorbable polymer) and is designed to remain in the vessel to provide support for the stenosed lesion until it degrades.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08717648213014	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

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