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Device Explorer · FDA GUDID · GMDN 35107

Middle ear incus hook

A shaft-like, hand-held manual surgical instrument intended to be used during ear/nose/throat (ENT) surgery for fixation or traction of the incus bone (the anvil bone of the group of three that form the sound-transmitting ossicles in the middle ear). The devic

US‑registered devices101in commercial distribution
Companies8labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription97%Rx‑only share
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Share of device records

Integra Lifesciences Production Corporation3131%
Gyrus Acmi, Llc2525%
Bear-Ent, Llc1717%
Jedmed Instrument Company1414%
Ambler Surgical Corp.1010%
American Medicals22%
Spiggle & Theis Medizintechnik Gmbh11%
Br Surgical, Llc11%

Top labelers

CompanyDevicesShare
Integra Lifesciences Production Corporation3131%
Gyrus Acmi, Llc2525%
Bear-Ent, Llc1717%
Jedmed Instrument Company1414%
Ambler Surgical Corp.1010%
American Medicals22%
Spiggle & Theis Medizintechnik Gmbh11%
Br Surgical, Llc11%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

House hookBR Surgical, LLCEVONOSAmbler SurgicalAmerican MedicalsJEDMEDIntegra® Jarit®Integra®BEAR

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

FDA product codes

CodeNameDevices
JYLHook, Microsurgical Ear32
LRCINSTRUMENT, ENT MANUAL SURGICAL26
JYLHOOK, MICROSURGICAL EAR26
GZXINSTRUMENT, MICROSURGICAL6
GDGHOOK, SURGICAL, GENERAL & PLASTIC SURGERY4
LRCInstrument, Ent Manual Surgical3

GMDN & GCC registration

  • GMDN code 35107 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 97% · 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

Angle (degree) · 10Length (Millimeter) · 7Outer Diameter (Millimeter) · 2Width (Millimeter) · 2Length (Inch) · 1Catheter Gauge (French) · 1

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

How many middle ear incus hook products are registered in the US?

101 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Middle ear incus hook", from 8 companies. The largest labeler is Integra Lifesciences Production Corporation with 31% of records.

Which FDA product codes apply?

JYL (Hook, Microsurgical Ear), LRC (INSTRUMENT, ENT MANUAL SURGICAL), JYL (HOOK, MICROSURGICAL EAR), GZX (INSTRUMENT, MICROSURGICAL)

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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