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Device Explorer · FDA GUDID · GMDN 62619

Surgical linen/cushion set

A collection of devices intended to be fitted to equipment used to support a patient during surgery (e.g., operating table) to provide a hygienic barrier and positioning/support capabilities. It typically includes operating table sheets, covers, pillows/cushio

US‑registered devices164in commercial distribution
Companies10labelers on GUDID
Single‑use95%of device records
Sterile1%labelled sterile
Prescription2%Rx‑only share
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Share of device records

Mizuho Orthopedic Systems, Inc.6741%
Innovative Medical Products, Inc4125%
Hill-Rom, Inc.2415%
Bosma Enterprises2314%
Conmed Corporation32%
Precision Dynamics Corporation21%
Maquet Gmbh11%
Arthrex, Inc.11%

Top labelers

CompanyDevicesShare
Mizuho Orthopedic Systems, Inc.6741%
Innovative Medical Products, Inc4125%
Hill-Rom, Inc.2415%
Bosma Enterprises2314%
Conmed Corporation32%
Precision Dynamics Corporation21%
Maquet Gmbh11%
Arthrex, Inc.11%
Aspen Surgical Products, Inc.11%
Allen Medical Systems, Inc.11%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Disposable coverArthrex®PKIT PROAXIS LPC SG HIP ARMPKIT, STS Trios, LPC, SG ARM PADORTHO LATERAL 3-PC COVER SETPKIT HANA LATERAL SET WITH BOOTPKIT HANA HIP AATHA, ARTHRO, TRAUMAPKIT HANA SUPINE, NO HEAD, NO BOOTPKIT HANA SUPINE, W/ BOOT, NO HEADPKIT HANA DISTRACTION PAD BASIC TRCPKIT HANA DISTRACTION PAD AATHA KITPKIT HANA DISTRACTION PAD HIP ARTHRPKIT, AXIS W/O ACP TUBEPKIT, AXIS, LPV, SG, W/TUBINGPKIT, INSITE, GENTLE TOUCH"Pkit, SST, 7"" GT Pillow, Arm Pad, Hip"

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

FDA product codes

CodeNameDevices
CCXSupport, Patient Position48
FMPProtector, Skin Pressure41
PWUClean-Up Kit23
KMEBEDDING, DISPOSABLE, MEDICAL15
KMEBedding, Disposable, Medical13
FMQRestraint, Protective7

GMDN & GCC registration

  • GMDN code 62619 · non‑implantable
  • Single‑use 95% · sterile 1% · Rx‑only 2% · 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 linen/cushion set products are registered in the US?

164 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical linen/cushion set", from 10 companies. The largest labeler is Mizuho Orthopedic Systems, Inc. with 41% of records.

Which FDA product codes apply?

CCX (Support, Patient Position), FMP (Protector, Skin Pressure), PWU (Clean-Up Kit), KME (BEDDING, DISPOSABLE, MEDICAL)

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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