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Device Explorer · FDA GUDID · GMDN 36235

Manual surgical rotary handpiece, reusable

A manually-powered, hand-held, surgical device intended to be used to provide rotary motion for an endpiece (not included) during a surgical procedure such as cutting, sculpting, trepanning, or drilling bone and driving Kirschner wires; it is not dedicated to

US‑registered devices462in commercial distribution
Companies59labelers on GUDID
Single‑use13%of device records
Sterile5%labelled sterile
Prescription66%Rx‑only share
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Share of device records

Vb Spine Llc5412%
Globus Medical, Inc.5011%
Hnm Stainless, Llc.5011%
Seaspine Orthopedics Corporation235%
Medos International Sàrl235%
Medicon Eg. Chirurgiemechaniker-Genossenschaft225%
Stryker Corporation204%
Philips Ds North America Llc204%

Top labelers

CompanyDevicesShare
Vb Spine Llc5412%
Globus Medical, Inc.5011%
Hnm Stainless, Llc.5011%
Seaspine Orthopedics Corporation235%
Medos International Sàrl235%
Medicon Eg. Chirurgiemechaniker-Genossenschaft225%
Stryker Corporation204%
Philips Ds North America Llc204%
Spineguard174%
Zavation Llc143%
Biomet Orthopedics, Llc123%
Citieffe Srl123%

Company = labeler of record on GUDID. 59 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NAOASYSREFLEX HYBRIDAVS Anchor-C Cervical Cage SystemPaltopHolder for guide wireActiva InstrumentApexMaxMoreSpineFENTEXRaspRZ Medizintechnik GmbHGimmin.a.BETTOCCHIAESCULAP

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 INSTRUMENT104
HTWBit, Drill73
LXHOrthopedic manual surgical instrument53
HTWBIT, DRILL49
HXYBRACE, DRILL27
KNWINSTRUMENT, BIOPSY20

GMDN & GCC registration

  • GMDN code 36235 · non‑implantable
  • Single‑use 13% · sterile 5% · Rx‑only 66% · 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

Length (Millimeter) · 72Outer Diameter (Millimeter) · 49Height (Millimeter) · 7Length (Inch) · 5Needle Gauge (Gauge) · 3

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

How many manual surgical rotary handpiece, reusable products are registered in the US?

462 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Manual surgical rotary handpiece, reusable", from 59 companies. The largest labeler is Vb Spine Llc with 12% of records.

Which FDA product codes apply?

LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), HTW (Bit, Drill), LXH (Orthopedic manual surgical instrument), HTW (BIT, DRILL)

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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