Device Explorer · FDA GUDID · GMDN 35915

Ear excavator

A hand-held manual surgical instrument designed for cutting, scraping, scooping and removing tissue during a surgical procedure in or around the ear, allowing the performance of specialized procedures such as removal of the cochlear cupola and microsurgery of

US‑registered devices315in commercial distribution
Companies17labelers on GUDID
Single‑use1%of device records
Sterile0%labelled sterile
Prescription31%Rx‑only share
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Share of device records

Surgical Direct, Inc.21669%
Steris Corporation165%
Avalign Technologies, Inc.134%
Boss Instruments, Ltd., Inc.124%
Ambler Surgical Corp.124%
Integra Lifesciences Production Corporation103%
Gyrus Acmi, Llc93%
Novo Surgical, Inc.62%

Top labelers

CompanyDevicesShare
Surgical Direct, Inc.21669%
Steris Corporation165%
Avalign Technologies, Inc.134%
Boss Instruments, Ltd., Inc.124%
Ambler Surgical Corp.124%
Integra Lifesciences Production Corporation103%
Gyrus Acmi, Llc93%
Novo Surgical, Inc.62%
Aesculap, Inc.52%
Surgix Medical Llc52%
Rz-Medizintechnik Gmbh41%
Bear-Ent, Llc21%

Company = labeler of record on GUDID. 17 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

RZ Medizintechnik GmbHAESCULAPBOSS InstrumentsSymmetry HoughNovo Surgical Inc.Gen2GEN2EVONOSGYRUS ACMI, INCMillenniumMILLENNIUMAvalignAmbler SurgicalSurgical DirectPILLINGV. Mueller

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

FDA product codes

CodeNameDevices
GENFORCEPS, GENERAL & PLASTIC SURGERY204
JYHEXCAVATOR, EAR51
GENForceps, General & Plastic Surgery17
LRCINSTRUMENT, ENT MANUAL SURGICAL14
JYHExcavator, Ear10
LXHOrthopedic manual surgical instrument7

GMDN & GCC registration

  • GMDN code 35915 · non‑implantable
  • Single‑use 1% · sterile 0% · Rx‑only 31% · 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 (Inch) · 10Angle (degree) · 1Length (Millimeter) · 1Width (Millimeter) · 1

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

How many ear excavator products are registered in the US?

315 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ear excavator", from 17 companies. The largest labeler is Surgical Direct, Inc. with 69% of records.

Which FDA product codes apply?

GEN (FORCEPS, GENERAL & PLASTIC SURGERY), JYH (EXCAVATOR, EAR), GEN (Forceps, General & Plastic Surgery), LRC (INSTRUMENT, ENT MANUAL SURGICAL)

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.

How do I get quotes?

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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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