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Device Explorer · FDA GUDID · GMDN 47831

Orthopaedic implantation sleeve, reusable

A hand-held tubular surgical device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sl

US‑registered devices2,569in commercial distribution
Companies114labelers on GUDID
Single‑use5%of device records
Sterile1%labelled sterile
Prescription94%Rx‑only share
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Share of device records

Synthes Gmbh27511%
Biomet Orthopedics, Llc24710%
Smith & Nephew, Inc.2219%
Medtronic Sofamor Danek, Inc.1285%
Stryker Gmbh1255%
Depuy Spine, Llc1044%
Jeil Medical Corporation934%
Paragon 28, Inc.924%

Top labelers

CompanyDevicesShare
Synthes Gmbh27511%
Biomet Orthopedics, Llc24710%
Smith & Nephew, Inc.2219%
Medtronic Sofamor Danek, Inc.1285%
Stryker Gmbh1255%
Depuy Spine, Llc1044%
Jeil Medical Corporation934%
Paragon 28, Inc.924%
Seaspine Orthopedics Corporation773%
Highridge Medical, Llc753%
Arthrex, Inc.713%
Cg Medtech Co.,Ltd.642%

Company = labeler of record on GUDID. 114 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

T2, PANGEAT2PANGEANAXia 3 System - SerratoAVIATORReflex HybridREFLEX HYBRIDXIA 3OASYSES2 SPINAL SYSTEMXIA 4.5 EVOLUTIONINSTRUMENTASNISHOFFMANNOMEGA

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 INSTRUMENT620
FZXGuide, surgical, instrument453
LXHOrthopedic manual surgical instrument290
LXHOrthopedic Manual Surgical Instrument258
FZXGuide, Surgical, Instrument183
GEACANNULA, SURGICAL, GENERAL & PLASTIC SURGERY108

GMDN & GCC registration

  • GMDN code 47831 · non‑implantable
  • Single‑use 5% · sterile 1% · Rx‑only 94% · 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) · 84Lumen/Inner Diameter (Millimeter) · 60Length (Millimeter) · 22Length (Inch) · 10Angle (degree) · 5Outer Diameter (Inch) · 2

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

How many orthopaedic implantation sleeve, reusable products are registered in the US?

2,569 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic implantation sleeve, reusable", from 114 companies. The largest labeler is Synthes Gmbh with 11% of records.

Which FDA product codes apply?

LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), FZX (Guide, surgical, instrument), LXH (Orthopedic manual surgical instrument), LXH (Orthopedic Manual Surgical Instrument)

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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