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AMDS Hybrid Prosthesis ("AMDS")

FDA UDI

Class III (US FDA UDI)

by Artivion, Inc.

Identity

Trade Name
AMDS Hybrid Prosthesis ("AMDS") FDA UDI
Generic Name
Bare-metal aortic stent FDA UDI
Device Name
55mm Straight Stent (32mm collar) FDA UDI
Model / Reference
K039422 FDA UDI
Description
55mm Straight Stent (32mm collar) FDA UDI

Identifiers

Catalog Number
AMDS55 FDA UDI
Primary DI / UDI-DI
00877234001215 FDA UDI
PMA Number
H230007 FDA UDI
FDA Product Code
QSK FDA UDI
GMDN Term
Bare-metal aortic stent FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Catheter Length — 565 Millimeter FDA UDI

Category: Bare-metal aortic stent

AMDS Hybrid Prosthesis ("AMDS") by Artivion, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bare-metal aortic stent.

Cleared under the same submission

H230007 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Artivion, Inc.

Sources (1)

  • FDA UDI d7cf0049-9917-445e-99f2-487d86ec429a 38 fields · synced Jun 8, 2026