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Device Explorer · FDA GUDID · GMDN 47457

Orthopaedic trocar blade, reusable

A rigid hand-held surgical instrument with a sharp (pyramidal or conical) point designed to be used during orthopaedic surgery for the manual puncture of a bodily entry point to: 1) gently part the surrounding soft tissue upon entry; 2) assist in the location

US‑registered devices894in commercial distribution
Companies63labelers on GUDID
Single‑use5%of device records
Sterile2%labelled sterile
Prescription91%Rx‑only share
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Share of device records

Arthrex, Inc.11213%
Biomet Orthopedics, Llc9010%
Kls-Martin L.P.9010%
Synthes Gmbh728%
Smith & Nephew, Inc.576%
Citieffe Srl404%
Stryker Gmbh394%
Karl Storz Gmbh & Co. Kg354%

Top labelers

CompanyDevicesShare
Arthrex, Inc.11213%
Biomet Orthopedics, Llc9010%
Kls-Martin L.P.9010%
Synthes Gmbh728%
Smith & Nephew, Inc.576%
Citieffe Srl404%
Stryker Gmbh394%
Karl Storz Gmbh & Co. Kg354%
Orthofix Srl293%
Wright Medical Technology, Inc.283%
Boss Instruments, Ltd., Inc.263%
American Medical Endoscopy, Inc.182%

Company = labeler of record on GUDID. 63 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NAPANGEAGAMMAANCHORAGEHOFFMANNSpeed-LockT2APEXPiccolo Composite Nailing SystemPiccolo Composite Plate SystemTrocar, φ8.1Trocar for Outer Protection Sleeve, for calibratTrocar Φ8.0Arthroscopy trocar 'Stryker',blunt, f.Stryker shArthroscopy trocar,blunt,OD 4.2mm, HIGH-FLOW,f.oApex

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

FDA product codes

CodeNameDevices
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT205
NBHAccessories, arthroscopic111
LXHOrthopedic manual surgical instrument77
HSBRod, Fixation, Intramedullary And Accessories65
LXHOrthopedic Manual Surgical Instrument61
FZXGuide, surgical, instrument61

GMDN & GCC registration

  • GMDN code 47457 · non‑implantable
  • Single‑use 5% · sterile 2% · Rx‑only 91% · 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) · 43Length (Millimeter) · 16Length (Inch) · 15Length (Centimeter) · 5Outer Diameter (Inch) · 3Width (Millimeter) · 2

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

How many orthopaedic trocar blade, reusable products are registered in the US?

894 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic trocar blade, reusable", from 63 companies. The largest labeler is Arthrex, Inc. with 13% of records.

Which FDA product codes apply?

LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), NBH (Accessories, arthroscopic), LXH (Orthopedic manual surgical instrument), HSB (Rod, Fixation, Intramedullary And Accessories)

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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