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Device Explorer · FDA GUDID · GMDN 45021

Instrument/equipment drape, single-use, sterile

A sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various surgical and/or non-surgical instruments/equipment [e.g., surgical tray, operating room (OR) equipment table, endoscope

US‑registered devices1,046in commercial distribution
Companies24labelers on GUDID
Single‑use82%of device records
Sterile39%labelled sterile
Prescription15%Rx‑only share
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Share of device records

Advance Medical Designs, Inc.37035%
Deroyal Industries, Inc.24123%
Microtek Medical Llc18718%
Medical Technique, Inc.12412%
O&M Halyard, Inc.283%
Carl Zeiss Meditec Ag192%
Spectrum, Inc.162%
Medline Industries, Inc.81%

Top labelers

CompanyDevicesShare
Advance Medical Designs, Inc.37035%
Deroyal Industries, Inc.24123%
Microtek Medical Llc18718%
Medical Technique, Inc.12412%
O&M Halyard, Inc.283%
Carl Zeiss Meditec Ag192%
Spectrum, Inc.162%
Medline Industries, Inc.81%
Mavig Gmbh71%
Protek Medical Products, Inc.71%
Techmedical Services, Inc.61%
Mckesson Medical-Surgical Inc.61%

Company = labeler of record on GUDID. 24 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NASMARTDRAPEDrapesVisionGuard® Replacement LensesOPMI® DrapesOPMI® Drapes sterileDRAPES sterileINTRABEAM® DrapeSeptishield II 80cmN/ADinamic OR Gerstner Double Wide Blue Cover LabelDinamic OR Gerstner Double Wide Orange Cover LabDinamic OR Spine Rack Monitor Cover 60x64cmHays InnovationsAustinSpectrum, Inc.

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

FDA product codes

CodeNameDevices
JAASystem, x-ray, fluoroscopic, image-intensified297
KKXDrape, surgical288
FTALight, surgical, accessories205
KKXDrape, Surgical107
ITXTransducer, ultrasonic, diagnostic67
HMWDrape, Microscope, Ophthalmic62

GMDN & GCC registration

  • GMDN code 45021 · non‑implantable
  • Single‑use 82% · sterile 39% · Rx‑only 15% · OTC 2%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Height (Inch) · 17Width (Inch) · 17Height (Centimeter) · 17Width (Centimeter) · 17

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

How many instrument/equipment drape, single-use, sterile products are registered in the US?

1,046 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Instrument/equipment drape, single-use, sterile", from 24 companies. The largest labeler is Advance Medical Designs, Inc. with 35% of records.

Which FDA product codes apply?

JAA (System, x-ray, fluoroscopic, image-intensified), KKX (Drape, surgical), FTA (Light, surgical, accessories), 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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