Consulting Wallah › Device Explorer › Procedure kits & trays › Orthopaedic surgical procedure kit, non-medicated,
Device Explorer · FDA GUDID · GMDN 44052

Orthopaedic surgical procedure kit, non-medicated, single-use

A collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals

US‑registered devices50,973in commercial distribution
Companies65labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Cardinal Health 200, Llc48,95296%
Aligned Medical Solutions1,3003%
Eca Medical Instruments970%
Medacta International Sa520%
Howmedica Osteonics Corp.330%
In2Bones330%
In2Bones Usa, Llc320%
Biomet Orthopedics, Llc310%

Top labelers

CompanyDevicesShare
Cardinal Health 200, Llc48,95296%
Aligned Medical Solutions1,3003%
Eca Medical Instruments970%
Medacta International Sa520%
Howmedica Osteonics Corp.330%
In2Bones330%
In2Bones Usa, Llc320%
Biomet Orthopedics, Llc310%
Newclip Technics300%
Mazor Robotics Ltd270%
Gramercy Extremity Orthopedics Llc270%
Kinamed, Inc.240%

Company = labeler of record on GUDID. 65 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

mild Device KitPivot GuardianT2 ALPHAINSTRUMENTHOFFMANNNACarboClear Posterior Cervical Screw SystemMazor X Spine Disposable KitMazor X Scan & Plan Disposable KitMinimally Invasive Disposable KitClamp Disposable KitCarboClear Pedicle Screw SystemBed Mount Disposable KitScan & Plan Bed Mount Disposables KitScan & Plan Clamp Disposable KitScan & Plan Minimally Invasive Disposable Kit

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

FDA product codes

CodeNameDevices
OJHOrthopedic tray49,379
OJHOrthopedic Tray1,518
LXHOrthopedic Manual Surgical Instrument218
KDDKit, surgical instrument, disposable77
KDDKit, Surgical Instrument, Disposable47
LXHOrthopedic manual surgical instrument46

GMDN & GCC registration

  • GMDN code 44052 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 100% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Outer Diameter (Millimeter) · 38Width (Millimeter) · 10Length (Millimeter) · 9Length (Centimeter) · 7Angle (degree) · 2Lumen/Inner Diameter (Millimeter) · 1

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

How many orthopaedic surgical procedure kit, non-medicated, single-use products are registered in the US?

50,973 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic surgical procedure kit, non-medicated, single-use", from 65 companies. The largest labeler is Cardinal Health 200, Llc with 96% of records.

Which FDA product codes apply?

OJH (Orthopedic tray), OJH (Orthopedic Tray), LXH (Orthopedic Manual Surgical Instrument), 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.

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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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