Device Explorer · FDA GUDID · GMDN 35802

Otologic clamp

A hand-held manual surgical instrument designed to grasp internal ear structures (e.g., a bone of the ossicles) during an ear/nose/throat (ENT) procedure. It typically has a self-retaining, scissors-like design with ring handles and is made of high-grade stain

US‑registered devices454in commercial distribution
Companies10labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription99%Rx‑only share
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Share of device records

Ambler Surgical Corp.38885%
Medicon Eg. Chirurgiemechaniker-Genossenschaft5312%
Integra Lifesciences Production Corporation41%
Aesculap, Inc.20%
Med Saver, Inc.20%
Accurate Surgical & Scientific Instruments Corporation10%
Hayden Medical, Inc.10%
Br Surgical, Llc10%

Top labelers

CompanyDevicesShare
Ambler Surgical Corp.38885%
Medicon Eg. Chirurgiemechaniker-Genossenschaft5312%
Integra Lifesciences Production Corporation41%
Aesculap, Inc.20%
Med Saver, Inc.20%
Accurate Surgical & Scientific Instruments Corporation10%
Hayden Medical, Inc.10%
Br Surgical, Llc10%
Jedmed Instrument Company10%
Anmuth Medical International, Llc10%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

AESCULAPMediconMedicon ForcepsASSIHayden MedicalBR Surgical, LLCMSI Precision Specialty InstrumentsAmbler SurgicalAmbler Value LineJEDMEDIntegra® Jarit®Integra®Anmuth Medical International

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

FDA product codes

CodeNameDevices
KAEFORCEPS, ENT391
KCBTUBE, TONSIL SUCTION20
GZXINSTRUMENT, MICROSURGICAL13
JYFCLAMP, OSSICLE HOLDING8
NNNCRIMPER, WIRE, ENT, NON-STERILE5
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE4

GMDN & GCC registration

  • GMDN code 35802 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 99% · 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) · 1

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

No closely related category with 50+ devices.

How many otologic clamp products are registered in the US?

454 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Otologic clamp", from 10 companies. The largest labeler is Ambler Surgical Corp. with 85% of records.

Which FDA product codes apply?

KAE (FORCEPS, ENT), KCB (TUBE, TONSIL SUCTION), GZX (INSTRUMENT, MICROSURGICAL), JYF (CLAMP, OSSICLE HOLDING)

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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