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Device Explorer · FDA GUDID · GMDN 58976

Medical equipment/instrument drape, reusable

A noninvasive flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tub

US‑registered devices86in commercial distribution
Companies12labelers on GUDID
Single‑use3%of device records
Sterile0%labelled sterile
Prescription56%Rx‑only share
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Share of device records

Carl Zeiss Meditec Ag2630%
Mizuho Orthopedic Systems, Inc.1821%
Pearl Technology Ag1619%
Medline Industries, Inc.1416%
Tzora Active Systems Ltd22%
Becton, Dickinson And Company22%
Oakworks, Inc.22%
Sontec Instruments, Inc.22%

Top labelers

CompanyDevicesShare
Carl Zeiss Meditec Ag2630%
Mizuho Orthopedic Systems, Inc.1821%
Pearl Technology Ag1619%
Medline Industries, Inc.1416%
Tzora Active Systems Ltd22%
Becton, Dickinson And Company22%
Oakworks, Inc.22%
Sontec Instruments, Inc.22%
Olympus Medical Systems Corp.11%
Cardinal Health 200, Llc11%
Skytron Llc11%
Hulaser, Inc.11%

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

Brand names on the register (sample)

TzoraKEYBOARD COVERSterilizable handgrip coverSterilizable sleeveSterilizable cap, 33mmSterilizable cap (OPMI Lumera 700)Sterilizable handgrip (rotatable 360°)Sterilizable cap, 62 mmSterilizable cap, 25 mmSterilizable handgrip cover (OPMI 1 FC)Sterilizable handgrip (OPMI VISU)Sterilizable cap, 27mmSterilizable cap, 49mmSterilizable cap, 49 mm (180° tiltable tube)Sterilizable cap, 12 mmSterilizable cap, 22mm

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

FDA product codes

CodeNameDevices
PUIDrape, Surgical, Exempt21
JEATable, Surgical With Orthopedic Accessories, Ac-Powered16
FMWCover, Mattress (Medical Purposes)16
KKXDrape, surgical13
KKXDrape, Surgical3
NWBEndoscope, accessories, narrow band spectrum2

GMDN & GCC registration

  • GMDN code 58976 · non‑implantable
  • Single‑use 3% · sterile 0% · Rx‑only 56% · OTC 17%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Width (Inch) · 4Height (Inch) · 3Height (Centimeter) · 2Width (Centimeter) · 2Length (Inch) · 1

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

How many medical equipment/instrument drape, reusable products are registered in the US?

86 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Medical equipment/instrument drape, reusable", from 12 companies. The largest labeler is Carl Zeiss Meditec Ag with 30% of records.

Which FDA product codes apply?

PUI (Drape, Surgical, Exempt), JEA (Table, Surgical With Orthopedic Accessories, Ac-Powered), FMW (Cover, Mattress (Medical Purposes)), 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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