Consulting Wallah › Device Explorer › Procedure kits & trays › Surgical patient preparation kit
Device Explorer · FDA GUDID · GMDN 35246

Surgical patient preparation kit

A collection of devices designed for the preoperative preparation of the operative site on a patient's body. It typically includes scrubbing pads (e.g., surgical sponges) and sterilizing/disinfecting solutions. This is a single-use device.

US‑registered devices371in commercial distribution
Companies11labelers on GUDID
Single‑use100%of device records
Sterile93%labelled sterile
Prescription85%Rx‑only share
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Share of device records

Cardinal Health 200, Llc14639%
Manus Medical, Llc7520%
Cardinal Health, Inc.5715%
Centurion Medical Products Corporation4111%
Deroyal Industries, Inc.246%
Medical Action Industries Inc.134%
Avid Medical, Inc.72%
Medline Industries, Inc.51%

Top labelers

CompanyDevicesShare
Cardinal Health 200, Llc14639%
Manus Medical, Llc7520%
Cardinal Health, Inc.5715%
Centurion Medical Products Corporation4111%
Deroyal Industries, Inc.246%
Medical Action Industries Inc.134%
Avid Medical, Inc.72%
Medline Industries, Inc.51%
Apollo Medical Products Corp.10%
Stradis Medical Llc10%
Icu Medical, Inc.10%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Manus Medical, LLCCustom Healthcare Systems, Inc.Custom Healthcare Systems Inc.Custom Healthcare Systems of VA, LLCCUSTOM HEALTHCARE SYSTEMS INCCustom Healthcare Systems, Inc.CUSTOM HEALTHCARE SYSTEMS, INCCUSTOM HEALTHCARE SYSTEMS, INC.CUSTOM HEALTHCARE SYSTEMSCustom Healthcare SystemsDeRoyalSterling Medical ProductsCenturionDevonStradis Medical, LLC.ECHOGLO

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

FDA product codes

CodeNameDevices
OJUSkin prep tray227
FSMTRAY, SURGICAL, INSTRUMENT55
LROGeneral Surgery Tray45
KDDKit, surgical instrument, disposable14
LROGeneral surgery tray13
KDDKit, Surgical Instrument, Disposable8

GMDN & GCC registration

  • GMDN code 35246 · non‑implantable
  • Single‑use 100% · sterile 93% · Rx‑only 85% · OTC 15%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

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

How many surgical patient preparation kit products are registered in the US?

371 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical patient preparation kit", from 11 companies. The largest labeler is Cardinal Health 200, Llc with 39% of records.

Which FDA product codes apply?

OJU (Skin prep tray), FSM (TRAY, SURGICAL, INSTRUMENT), LRO (General Surgery Tray), KDD (Kit, surgical instrument, disposable)

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.

How do I get quotes?

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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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