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Device Explorer · FDA GUDID · GMDN 64134

Patient radiation shielding pad/drape, single-use

A protective device intended to be placed on/draped over part of a patient’s body during a diagnostic or therapeutic radiological procedure to shield specific patient anatomies from unnecessary exposure to radiation and/or help block scatter radiation from the

US‑registered devices87in commercial distribution
Companies7labelers on GUDID
Single‑use100%of device records
Sterile75%labelled sterile
Prescription14%Rx‑only share
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Share of device records

Angiosystems, Incorporated3743%
Worldwide Innovations & Technologies, Inc.2326%
Uniray Medical Llp910%
Microtek Medical Llc78%
Barrier Technologies, Llc56%
Manus Medical, Llc45%
Radux Devices, Llc22%

Top labelers

CompanyDevicesShare
Angiosystems, Incorporated3743%
Worldwide Innovations & Technologies, Inc.2326%
Uniray Medical Llp910%
Microtek Medical Llc78%
Barrier Technologies, Llc56%
Manus Medical, Llc45%
Radux Devices, Llc22%

Company = labeler of record on GUDID. 7 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Steradian ShieldRADPADAngioSystems SorbXHalyard Scatter Radiation ShieldsManus Medical, LLCMedline-Microtek"SecureShield© Multipurpose 12"" x 36"" Scatter "SecureShield© for Dialysis 42"" x 32"" Scatter "SecureShield© EP 12"" x 17"" Scatter Reducing D"SecureShield© Angiography 13"" x 16"" Scatter R"SecureShield© Multipurpose with fenestration 12UniRay

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, Personnel53
PUIDrape, surgical, exempt17
PUIDrape, Surgical, Exempt9
KPYShield, protective, personnel6
LWXDevice. Laser Peripheral Angioplasty2
IWXBarrier, Control Panel, X-Ray, Movable1

GMDN & GCC registration

  • GMDN code 64134 · non‑implantable
  • Single‑use 100% · sterile 75% · Rx‑only 14% · OTC 10%
  • 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 patient radiation shielding pad/drape, single-use products are registered in the US?

87 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Patient radiation shielding pad/drape, single-use", from 7 companies. The largest labeler is Angiosystems, Incorporated with 43% of records.

Which FDA product codes apply?

KPY (Shield, Protective, Personnel), PUI (Drape, surgical, exempt), PUI (Drape, Surgical, Exempt), KPY (Shield, protective, personnel)

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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