Consulting Wallah › Device Explorer › Other devices › Tympanotomy knife, single-use
Device Explorer · FDA GUDID · GMDN 63660

Tympanotomy knife, single-use

A hand-held, manual surgical instrument designed to cut or pierce the eardrum (tympanic membrane) during ear/nose/throat (ENT) surgery, frequently for insertion of a drainage tube in cases of inflammation of the middle ear. Otherwise known as myringotomy knife

US‑registered devices67in commercial distribution
Companies10labelers on GUDID
Single‑use84%of device records
Sterile97%labelled sterile
Prescription82%Rx‑only share
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Share of device records

Ambler Surgical Corp.2233%
Gyrus Acmi, Llc1218%
Summit Medical, Inc.1116%
Beaver-Visitec International, Inc.913%
Integra Lifesciences Production Corporation46%
Dtr Medical Limited23%
Br Surgical, Llc23%
Med Saver, Inc.23%

Top labelers

CompanyDevicesShare
Ambler Surgical Corp.2233%
Gyrus Acmi, Llc1218%
Summit Medical, Inc.1116%
Beaver-Visitec International, Inc.913%
Integra Lifesciences Production Corporation46%
Dtr Medical Limited23%
Br Surgical, Llc23%
Med Saver, Inc.23%
Jedmed Instrument Company23%
Adept Medical Limited11%

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

Brand names on the register (sample)

Rosen Needle Fine 160mmRosen Needle 160mmBR Surgical, LLCGyrus ACMIN/AMSI Precision Specialty InstrumentsBeaver®ADEPT MEDICALIntegra®Ambler SurgicalAdept Medical Myringotomy Knife

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

FDA product codes

CodeNameDevices
JYOKNIFE, EAR24
LRCINSTRUMENT, ENT MANUAL SURGICAL14
KDCInstrument, Surgical, Disposable11
GESBLADE, SCALPEL7
JYPKnife, Myringotomy5
JYPKNIFE, MYRINGOTOMY4

GMDN & GCC registration

  • GMDN code 63660 · non‑implantable
  • Single‑use 84% · sterile 97% · Rx‑only 82% · 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

No structured size data on the register.

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

How many tympanotomy knife, single-use products are registered in the US?

67 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Tympanotomy knife, single-use", from 10 companies. The largest labeler is Ambler Surgical Corp. with 33% of records.

Which FDA product codes apply?

JYO (KNIFE, EAR), LRC (INSTRUMENT, ENT MANUAL SURGICAL), KDC (Instrument, Surgical, Disposable), GES (BLADE, SCALPEL)

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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