Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3035252867

FEI Number

3035252867

Entity Name

ISOGUARDIAN

City/State/Country

Albany, NY, US

Establishment Address

279 Central Avenue, Albany, NY 12206, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

ISOGuardian (Owner Number: 10092315)

Owner / Operator Contact Address

279 Central Avenue, Albany, NY 12206, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IG_L2M3

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2024-12-23

Official Correspondent

Sara Rudin

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ISOGuardian

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3035252867. Last updated year: 2026. Please use registration number 3035252867 when referencing this establishment in official correspondence.