Consulting Wallah › Device Explorer › Endoscopy & surgical instruments › Medical equipment/instrument drape, single-use
Device Explorer · FDA GUDID · GMDN 12535

Medical equipment/instrument drape, single-use

A 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, tubes, headrest

US‑registered devices3,720in commercial distribution
Companies164labelers on GUDID
Single‑use97%of device records
Sterile54%labelled sterile
Prescription29%Rx‑only share
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Share of device records

Microtek Medical Llc75820%
Preferred Medical Products, Llc3289%
Tidi Products, Llc2326%
Exact Medical Manufacturing, Inc.2126%
Owens & Minor Distribution, Inc.1594%
Plasdent Corporation1424%
Advance Medical Designs, Inc.1374%
Das Medical International Srl1123%

Top labelers

CompanyDevicesShare
Microtek Medical Llc75820%
Preferred Medical Products, Llc3289%
Tidi Products, Llc2326%
Exact Medical Manufacturing, Inc.2126%
Owens & Minor Distribution, Inc.1594%
Plasdent Corporation1424%
Advance Medical Designs, Inc.1374%
Das Medical International Srl1123%
Gri Medical & Electronic Technology Co., Ltd.1003%
Spiggle & Theis Medizintechnik Gmbh782%
Pharma Sept Medical Products (1995) Ltd.612%
Medline Industries, Inc.592%

Company = labeler of record on GUDID. 164 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Smith and NephewSterimedAtecRampartStrykerMedical Micro InstrumentProcept BioroboticsPROtegerMoon SurgicalAsensusProtegerTransEnterixTranEnterixVALO™ Barrier SleevesMIXPAC Protective SleeveC20 Intraoral Protective Sheaths

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, Exempt1,023
KKXDrape, surgical658
KKXDrape, Surgical634
PUIDrape, surgical, exempt476
JAASystem, X-Ray, Fluoroscopic, Image-Intensified329
PEMDental Barriers And Sleeves284

GMDN & GCC registration

  • GMDN code 12535 · non‑implantable
  • Single‑use 97% · sterile 54% · Rx‑only 29% · OTC 23%
  • 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) · 49Width (Inch) · 38Width (Centimeter) · 14Length (Centimeter) · 12Outer Diameter (Millimeter) · 11Length (Millimeter) · 4

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

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

3,720 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Medical equipment/instrument drape, single-use", from 164 companies. The largest labeler is Microtek Medical Llc with 20% of records.

Which FDA product codes apply?

PUI (Drape, Surgical, Exempt), KKX (Drape, surgical), KKX (Drape, Surgical), PUI (Drape, surgical, exempt)

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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