Consulting Wallah › Device Explorer › Cardiovascular › Cardiovascular patch, synthetic
Device Explorer · FDA GUDID · GMDN 31744

Cardiovascular patch, synthetic

An implantable material designed to reinforce suture lines and/or increase the strength of weak or injured cardiac and/or peripheral vascular tissues during cardiovascular repair/reconstruction procedures (e.g., annulus or septal defect repair, endarterectomy,

US‑registered devices234in commercial distribution
Companies8labelers on GUDID
Single‑use100%of device records
Sterile99%labelled sterile
Prescription94%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Teleflex Incorporated14763%
Bard Peripheral Vascular, Inc.4118%
Solinas Medical Inc.156%
W. L. Gore & Associates, Inc.125%
Deroyal Industries, Inc.104%
Covidien Lp52%
Stradis Medical, Llc31%
Corcym Inc.10%

Top labelers

CompanyDevicesShare
Teleflex Incorporated14763%
Bard Peripheral Vascular, Inc.4118%
Solinas Medical Inc.156%
W. L. Gore & Associates, Inc.125%
Deroyal Industries, Inc.104%
Covidien Lp52%
Stradis Medical, Llc31%
Corcym Inc.10%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

DEKNATELImpra® ePTFE Cardiovascular PatchBard® PTFE Felt PledgetBard® PTFE FeltBard® PTFE Felt PledgetsBard® PTFE Thick Felt PledgetsBard® PTFE Felt (Thick)Bard® DeBakey® Woven Polyester FabricBard® Sauvage® Filamentous Knitted Polyester FabBard® DeBakey® Double Velour Knitted Polyester FBard® PTFE Felt (Low Porosity)DeRoyalGORE-TEX Cardiovascular PatchReTAP® Cardiovascular PatchReTAP(TM) Cardiovascular PatchSTRADIS HEALTHCARE

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, POLYPROPYLENE194
DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene34
GATSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE32
GAWSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE7
OEZCardiovascular Procedure Kit4
OMRVessel guard or cover2

GMDN & GCC registration

  • GMDN code 31744 · implantable
  • Single‑use 100% · sterile 99% · Rx‑only 94% · 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 (Centimeter) · 205Width (Centimeter) · 57Height (Millimeter) · 15Width (Millimeter) · 9Length (Millimeter) · 9Height (Centimeter) · 3

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

How many cardiovascular patch, synthetic products are registered in the US?

234 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cardiovascular patch, synthetic", from 8 companies. The largest labeler is Teleflex Incorporated with 63% of records.

Which FDA product codes apply?

DXZ (PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE), DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene), GAT (SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE), GAW (SUTURE, NONABSORBABLE, SYNTHETIC, 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.

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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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