Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008979241

FEI Number

3008979241

Entity Name

ORTHONU, LLC

City/State/Country

Rumson, NJ, US

Establishment Address

17 Auldwood Lane, Rumson, NJ 07760, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OrthoNu, LLC (Owner Number: 10081935)

Owner / Operator Contact Address

17 Auldwood Lane, Rumson, NJ 07760, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Oral Relief Kitz Oral Relief Collection Mouth-Aid Comfort Tape

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2024-04-15

Official Correspondent

Sima Yakoby Epstein

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OrthoNu, 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 3008979241. Last updated year: 2026. Please use registration number 3008979241 when referencing this establishment in official correspondence.