Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016255836

FEI Number

3016255836

Entity Name

STERILAB, INC.

City/State/Country

Naples, FL, US

Establishment Address

1040 Morningside Drive, Naples, FL 34103, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Sterilab, Inc. (Owner Number: 10062164)

Owner / Operator Contact Address

1040 Morningside Drive, Naples, FL 34103, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NO POKE Non-Penetrating Mineral Oil Enema for Impaction Relief

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FCE	Enema Kit	Gastroenterology, Urology	Class 1	876.5210	2022-08-25

Official Correspondent

Joseph Cant

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Sterilab, Inc.

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 3016255836. Last updated year: 2026. Please use registration number 3016255836 when referencing this establishment in official correspondence.