ONTOGEN MANUFACTURING LLC

FDA Device Registration & Listing · Lisle, IL, US · Registration 3038472982

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3038472982
FEI Number
3038472982
Entity Name
ONTOGEN MANUFACTURING LLC
City/State/Country
Lisle, IL, US
Establishment Address
815 Ogden Ave, Lisle, IL 60532, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Ontogen Manufacturing LLC (Owner Number: 10093548)
Owner / Operator Contact Address
815 Ogden Avenue, Lisle, IL 60532, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FON Bag, Drainage, With Adhesive, Ostomy Gastroenterology, Urology Class 1 876.5900 2025-12-19
EYI Adaptor, Ureteral Catheter Gastroenterology, Urology Class 1 876.5130 2026-05-15
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2025-06-02

Official Correspondent

Michael Corrigan

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Ontogen Manufacturing 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 3038472982. Last updated year: 2026. Please use registration number 3038472982 when referencing this establishment in official correspondence.
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