Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1225968

FEI Number

3002480801

Entity Name

ENDOCRAFT LLC.

City/State/Country

Newton, MA, US

Establishment Address

100 Bellevue St, Newton, MA 02458, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ENDOCRAFT LLC. (Owner Number: 9035069)

Owner / Operator Contact Address

100 Bellevue St, Newton, MA 02458, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Zeitels Suction Cannula Zeitels Suspension Gallows UNIVERSAL MODULAR GLOTTISCOPE European Handle Extension Slim UMG Zeitels Intubation Scope Zeitels VOCAL FOLD INFUSION NEEDLE Light Cable Light Carrier

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2010-04-06
EBR	Unit, Suction Operatory	Dental	Class 1	872.6640	2023-07-18
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	1998-09-17
KAA	Set, Laryngeal Injection	Ear, Nose, Throat	Class 1	874.4420	1998-09-17
FEM	Accessories, Photographic, For Endoscope (Exclude Light Sources)	Gastroenterology, Urology	Class 1	876.1500	2023-07-06

Official Correspondent

STEVEN ZEITELS

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ENDOCRAFT LLC.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K940152	Hydro-Med Products, Inc.	CAMERA COVER WITH TEAR TIP	1994-10-28

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 1225968. Last updated year: 2026. Please use registration number 1225968 when referencing this establishment in official correspondence.