AccessGUDID - DEVICE: AMDS Hybrid Prosthesis ("AMDS") (00877234001192)

GUDID

Device Identifier (DI) Information

Brand Name: AMDS Hybrid Prosthesis ("AMDS")
Version or Model: K039420
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AMDS40
Company Name: Artivion, Inc.

Primary DI Number: 00877234001192
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119253177 *Terms of Use

Device Description: 40mm Straight Stent (24mm collar)

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
43521	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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
QSK	Hybrid Stent Graft, Thoracic Aortic Lesion Treatment

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
H230007	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 0 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Catheter Length: 527 Millimeter
Device Size Text, specify: Aortic Stent Proximal Diameter: 20-35mm
Device Size Text, specify: Aortic Stent Distal Diameter: 25-35mm
Device Size Text, specify: Aortic Stent Minimum Length:153mm
Device Size Text, specify: Aortic Stent Maximum Length:207mm
Device Size Text, specify: Stent Collar Diameter: 24mm

Device Record Status

Public Device Record Key: 097aa6d4-3029-4fc5-900d-8b9f5581d3b1
Public Version Date: February 13, 2025
Public Version Number: 1
DI Record Publish Date: February 05, 2025