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Device Explorer · FDA GUDID · GMDN 64601

Radiation shielding table drape

A protective device intended to be placed on/draped over part of an operating table for a radiological examination during a surgical procedure (e.g. fluoroscopy using a C-arm) to shield attending healthcare personnel from unnecessary exposure to radiation. It

US‑registered devices88in commercial distribution
Companies6labelers on GUDID
Single‑use12%of device records
Sterile2%labelled sterile
Prescription0%Rx‑only share
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Share of device records

Aadco Medical, Inc.5967%
Texray Ab1719%
Burlington Medical, Llc78%
Egg Medical, Inc.22%
Angiosystems, Incorporated22%
Barrier Technologies, Llc11%

Top labelers

CompanyDevicesShare
Aadco Medical, Inc.5967%
Texray Ab1719%
Burlington Medical, Llc78%
Egg Medical, Inc.22%
Angiosystems, Incorporated22%
Barrier Technologies, Llc11%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

MasterPeace"SecureShield© Multipurpose 12"" x 17"" Scatter EggNestAADCORayshieldDRAPEAngiosystems incAngioSystems SorbX

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

FDA product codes

CodeNameDevices
KPYShield, Protective, Personnel67
IWXBarrier, Control Panel, X-Ray, Movable14
EAKScreen, Leaded, Operator Radiation Protector7

GMDN & GCC registration

  • GMDN code 64601 · non‑implantable
  • Single‑use 12% · sterile 2% · Rx‑only 0% · 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

Width (Centimeter) · 17Length (Centimeter) · 17

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

How many radiation shielding table drape products are registered in the US?

88 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Radiation shielding table drape", from 6 companies. The largest labeler is Aadco Medical, Inc. with 67% of records.

Which FDA product codes apply?

KPY (Shield, Protective, Personnel), IWX (Barrier, Control Panel, X-Ray, Movable), EAK (Screen, Leaded, Operator Radiation Protector)

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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