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Device Explorer · FDA GUDID · GMDN 61625

Cadaveric pulmonary artery bioprosthesis

An implantable heart tissue allograft obtained from a human cadaver intended to be implanted in the heart during open heart surgery, to be used for repair or reconstruction of a dysfunctional right ventricular outflow tract. It is aseptically processed, and tr

US‑registered devices513in commercial distribution
Companies2labelers on GUDID
Single‑use100%of device records
Sterile0%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Lifenet Health51099%
Artivion, Inc.31%

Top labelers

CompanyDevicesShare
Lifenet Health51099%
Artivion, Inc.31%

Company = labeler of record on GUDID. 2 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

CardioGRAFT-MC™CardioGRAFT-MCCryoPatch® SG Pulmonary Human Cardiac Branch PatCryoPatch® SG Pulmonary Human Cardiac Trunk PatcCryoPatch® SG Pulmonary Human Cardiac Hemi-Arter

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene513

GMDN & GCC registration

  • GMDN code 61625 · implantable
  • Single‑use 100% · sterile 0% · Rx‑only 100% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Millimeter) · 508Width (Millimeter) · 506

Use these as the dimensions to specify in a tender line.

No closely related category with 50+ devices.

How many cadaveric pulmonary artery bioprosthesis products are registered in the US?

513 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cadaveric pulmonary artery bioprosthesis", from 2 companies. The largest labeler is Lifenet Health with 99% of records.

Which FDA product codes apply?

DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

How do I get quotes?

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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