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Device Explorer · FDA GUDID · GMDN 47783

Patient surgical drape, single-use

A noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat

US‑registered devices4,909in commercial distribution
Companies80labelers on GUDID
Single‑use100%of device records
Sterile63%labelled sterile
Prescription10%Rx‑only share
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Share of device records

Gri Medical & Electronic Technology Co., Ltd.1,02021%
Cardinal Health 200, Llc94019%
O&M Halyard, Inc.72415%
Medline Industries, Inc.4569%
Microtek Medical Llc3627%
3M Company2645%
Aadco Medical, Inc.1313%
Welmed Inc.972%

Top labelers

CompanyDevicesShare
Gri Medical & Electronic Technology Co., Ltd.1,02021%
Cardinal Health 200, Llc94019%
O&M Halyard, Inc.72415%
Medline Industries, Inc.4569%
Microtek Medical Llc3627%
3M Company2645%
Aadco Medical, Inc.1313%
Welmed Inc.972%
Angiosystems, Incorporated872%
Henry Schein, Inc.802%
Mckesson Medical-Surgical Inc.731%
Albahealth, Llc721%

Company = labeler of record on GUDID. 80 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SchaererDASSurgical System Sleeve,10 PackSterile Clear Sleeve,10 packSurgical System Sterile Sleeve, 10 PackSurgeon's Screen Sterile Sleeve,10 packSurgeon's screen Sterile Sleeve,10 packSurgical System Sleeve, 10 PackSterile Cover For Device, 10 packReplacement Kit, Sterile Sheath, 10 packExact Medical Manufacturing, Inc.Best SealOpsite Incise 55x45cm Ctn 10Opsite Incise 28x45cm Ctn 10OPSITE INCISE 28X30CM CTN 10OPSITE INCISE 15X28CM CTN 10

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, exempt2,294
PUIDrape, Surgical, Exempt1,365
KKXDrape, surgical1,083
KKXDrape, Surgical729
IWQCurtain, Protective, Radiographic130
HMTDrape, patient, ophthalmic49

GMDN & GCC registration

  • GMDN code 47783 · non‑implantable
  • Single‑use 100% · sterile 63% · Rx‑only 10% · OTC 32%
  • 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) · 61Width (Inch) · 60Length (Centimeter) · 3Weight (Gram) · 2

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

How many patient surgical drape, single-use products are registered in the US?

4,909 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Patient surgical drape, single-use", from 80 companies. The largest labeler is Gri Medical & Electronic Technology Co., Ltd. with 21% of records.

Which FDA product codes apply?

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