Home GUDID 00877234001215 "AMDS Hybrid Prosthesis (""AMDS"")"
Primary DI 00877234001215
Brand "AMDS Hybrid Prosthesis (""AMDS"")"
Company Artivion, Inc.
Model K039422
Catalog number AMDS55
Device description 55mm Straight Stent (32mm collar)
Published 2025-02-05
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name QSK Hybrid Stent Graft, Thoracic Aortic Lesion Treatment
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QSK Hybrid Stent Graft, Thoracic Aortic Lesion Treatment Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00877234001215 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00877234001215 00877234001215 877234001215 0877234001215
GMDN Terms# Term, Definition table Term Definition Bare-metal aortic stent A non-bioabsorbable tubular device intended to be implanted in the aorta to maintain aortic patency and improve luminal diameter in patients with symptomatic atherosclerotic disease or recurrent coarctation (narrowing) of the aorta. It is made of metal (e.g., platinum/iridium wire with gold braze) and may be inserted with a balloon catheter which when inflated causes the device to expand, or the device may self-expand after being delivered to the site of implantation. The device is typically a mesh structure in tubular form; it is available in a variety of lengths and diameters. Disposable devices associated with implantation may be included.
Device Sizes# Type, Value, Unit table Type Value Unit Catheter Length 565 Millimeter Device Size Text, specify 0 Device Size Text, specify 0 Device Size Text, specify 0 Device Size Text, specify 0 Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 0 Degrees Celsius 25 Degrees Celsius
Regulatory Flags# DUNS number 119253177 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00877234001635 PhotoFix Decellularized Bovine Pericardium PFP6X8 PFP6X8 2026-05-29 00877234001642 PhotoFix Decellularized Bovine Pericardium PFP0.8X8 PFP0.8X8 2026-05-29 00877234001659 PhotoFix Decellularized Bovine Pericardium PFP1X6 PFP1X6 2026-05-29 00877234001666 PhotoFix Decellularized Bovine Pericardium PFP4X4 PFP4X4 2026-05-29 00877234001673 PhotoFix Decellularized Bovine Pericardium PFP2X9 PFP2X9 2026-05-29 00877234001680 PhotoFix Decellularized Bovine Pericardium PFP1X10 PFP1X10 2026-05-29 00877234001697 PhotoFix Decellularized Bovine Pericardium PFP1X14 PFP1X14 2026-05-29 00877234001703 PhotoFix Decellularized Bovine Pericardium PFP8X14 PFP8X14 2026-05-29 00877234000096 CardioGenesis NS2000 LSR-SG2100S 2016-12-12 00877234000447 CryoValve® SG Pulmonary Human Heart Valve SGPV00 SGPV00 2015-09-11 00877234000454 CryoValve® SG Pulmonary Human Heart Valve SGPV10 SGPV10 2015-09-11 00877234000102 CardioGenesis HP-SG3 HP-SG3 2016-12-12 00877234001192 "AMDS Hybrid Prosthesis (""AMDS"")" K039420 AMDS40 2025-02-05 00877234001208 "AMDS Hybrid Prosthesis (""AMDS"")" K039421 AMDS4030 2025-02-05 00877234001222 "AMDS Hybrid Prosthesis (""AMDS"")" K039423 AMDS5540 2025-02-05 00877234001321 "AMDS Hybrid Prosthesis (""AMDS"")" K038896 AMDS4030c 2025-02-05 00877234001338 "AMDS Hybrid Prosthesis (""AMDS"")" K038895 AMDS40c 2025-02-05 10877234001298 BioGlue Surgical Adhesive BG3510-5-US BG3510-5-US 2024-03-13 10877234001304 BioGlue Surgical Adhesive BG3515-5-US BG3515-5-US 2024-03-13 00877234000898 BioGlue Surgical Adhesive BGAT-27-SY BGAT-27-SY 2024-03-13
Other Devices Sharing Product Codes# 
artivion.com