Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011497859

FEI Number

3011497859

Entity Name

PEAK MEDICAL LTD.

City/State/Country

Netanya Central, IL

Establishment Address

10, Giborei, Netanya Central 4250410, IL

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Peak Medical Ltd. (Owner Number: 10047899)

Owner / Operator Contact Address

10, Giborei Israel, Netanya, IL-NOTA 4250410, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Tracheal Catheter Compact laryngoscope Neonatal laryngoscope Peak VN video laryngoscope kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JCY	Catheter, Infusion	General, Plastic Surgery	Class 1	878.4200	2018-11-29
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2014-11-13

Official Correspondent

Evgeny Pecherer

US Agent Details

Amy Pieper Business: International Biomedical Email: regulatory@int-bio.com Phone: (512) 8730033

Related Public Records

Same Entity

Peak Medical Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0144-2024	Covidien	1	Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Z-0169-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011497859. Last updated year: 2026. Please use registration number 3011497859 when referencing this establishment in official correspondence.