Consulting Wallah › Device Explorer › Procedure kits & trays › Cardiothoracic surgical procedure kit, medicated,
Device Explorer · FDA GUDID · GMDN 46408

Cardiothoracic surgical procedure kit, medicated, single-use

A collection of various sterile cardiothoracic surgical instruments, dressings, and materials including a pharmaceutical component, intended to be used to assist a range of cardiothoracic surgical procedures. The kit is intended only for use during cardiothora

US‑registered devices30,956in commercial distribution
Companies4labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Cardinal Health 200, Llc27,38288%
Avid Medical, Inc.3,56612%
Aligned Medical Solutions60%
Medical Action Industries Inc.20%

Top labelers

CompanyDevicesShare
Cardinal Health 200, Llc27,38288%
Avid Medical, Inc.3,56612%
Aligned Medical Solutions60%
Medical Action Industries Inc.20%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

CARDINAL HEALTHAligned Medical SolutionsHalyardAVID TruCustom

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

FDA product codes

CodeNameDevices
OEZCardiovascular procedure kit22,509
OEQAngiography/angioplasty kit5,299
OESCardiac catheterization kit1,832
LROGeneral surgery tray393
OFFCentral venous catheter tray258
OFGCT biopsy tray229

GMDN & GCC registration

  • GMDN code 46408 · non‑implantable
  • Single‑use 100% · sterile 100% · 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

No structured size data on the register.

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

How many cardiothoracic surgical procedure kit, medicated, single-use products are registered in the US?

30,956 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cardiothoracic surgical procedure kit, medicated, single-use", from 4 companies. The largest labeler is Cardinal Health 200, Llc with 88% of records.

Which FDA product codes apply?

OEZ (Cardiovascular procedure kit), OEQ (Angiography/angioplasty kit), OES (Cardiac catheterization kit), LRO (General surgery tray)

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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