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Device Explorer · FDA GUDID · GMDN 44713

Body-surface ultrasound imaging transducer cover

A device/material intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gels) and/or to maintain the required hygienic level of an ultrasound system imaging transducer (probe) used on the bod

US‑registered devices466in commercial distribution
Companies17labelers on GUDID
Single‑use87%of device records
Sterile67%labelled sterile
Prescription59%Rx‑only share
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Share of device records

Protek Medical Products, Inc.15734%
Civco Medical Instruments Co., Inc.10322%
Microtek Medical Llc6113%
Owens & Minor Distribution, Inc.5011%
Medxpress.Pro327%
Exact Medical Manufacturing, Inc.174%
Sheathing Technologies, Inc.153%
Bard Access Systems, Inc.92%

Top labelers

CompanyDevicesShare
Protek Medical Products, Inc.15734%
Civco Medical Instruments Co., Inc.10322%
Microtek Medical Llc6113%
Owens & Minor Distribution, Inc.5011%
Medxpress.Pro327%
Exact Medical Manufacturing, Inc.174%
Sheathing Technologies, Inc.153%
Bard Access Systems, Inc.92%
Mckesson Medical-Surgical Inc.61%
Marketlab Inc.51%
Parker Laboratories Inc31%
Hr Pharmaceuticals Inc.20%

Company = labeler of record on GUDID. 17 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Exact Medical Manufacturing, Inc.EZCOVER® STOP Gel-FreeEZCOVER® STOP Gel-VisionEZCOVER® Gel-FreeEZCOVER® Gel-VisionHays IncCoverallsSterile Single-Use Probe Cover KitGeneral Purpose Probe CoverPullUp Probe Cover KitPullUp Sterile Single-Use Probe Cover KitPullUp Instrument CoverMulti-Angle Biopsy Starter KitMulti Angle Biopsy Starter KitEndocavity Probe Cover with Rubber BandsDirector Biopsy/Needle Guide/PullUp Probe Cover

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

FDA product codes

CodeNameDevices
ITXTransducer, ultrasonic, diagnostic165
ITXTransducer, Ultrasonic, Diagnostic87
KKXDrape, Surgical82
KKXDrape, surgical38
PUIDrape, Surgical, Exempt29
OIPRadiology-Diagnostic Kit6

GMDN & GCC registration

  • GMDN code 44713 · non‑implantable
  • Single‑use 87% · sterile 67% · Rx‑only 59% · 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 (Inch) · 47Width (Inch) · 36Width (Centimeter) · 33Length (Centimeter) · 33Needle Gauge (Gauge) · 3Total Volume (Milliliter) · 2

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

How many body-surface ultrasound imaging transducer cover products are registered in the US?

466 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Body-surface ultrasound imaging transducer cover", from 17 companies. The largest labeler is Protek Medical Products, Inc. with 34% of records.

Which FDA product codes apply?

ITX (Transducer, ultrasonic, diagnostic), ITX (Transducer, Ultrasonic, Diagnostic), KKX (Drape, Surgical), 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.

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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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