Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003342406

FEI Number

3003342406

Entity Name

STEVEN LABEL LLC

City/State/Country

Santa Fe Springs, CA, US

Establishment Address

11926 Burke St, Santa Fe Springs, CA 90670, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Steven Label LLC (Owner Number: 10095522)

Owner / Operator Contact Address

11926 Burke Street, Santa Fe Springs, CA 90670, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SAM ThoraSite

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2026-03-24

Official Correspondent

Ken Klein C/O Steven Labe

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Steven Label LLC

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 3003342406. Last updated year: 2026. Please use registration number 3003342406 when referencing this establishment in official correspondence.