Device Explorer · FDA GUDID · GMDN 43071

X-ray system cover

A sterile piece of material used to cover an x-ray system during a surgical procedure to create a sterile barrier between the sterile operating field and the x-ray system, or the prominent parts of the x-ray system that intrude the sterile field. Since x-ray s

US‑registered devices63in commercial distribution
Companies2labelers on GUDID
Single‑use100%of device records
Sterile67%labelled sterile
Prescription0%Rx‑only share
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Share of device records

Sterimed Llc5587%
Microtek Medical Llc813%

Top labelers

CompanyDevicesShare
Sterimed Llc5587%
Microtek Medical Llc813%

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

Brand names on the register (sample)

SterimedMICROTEK

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

FDA product codes

CodeNameDevices
IZISystem, X-Ray, Angiographic55
KKXDrape, surgical8

GMDN & GCC registration

  • GMDN code 43071 · non‑implantable
  • Single‑use 100% · sterile 67% · Rx‑only 0% · OTC 87%
  • 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 x-ray system cover products are registered in the US?

63 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "X-ray system cover", from 2 companies. The largest labeler is Sterimed Llc with 87% of records.

Which FDA product codes apply?

IZI (System, X-Ray, Angiographic), KKX (Drape, surgical)

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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