Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003676119

FEI Number

3003676119

Entity Name

WASATCH PRODUCT DEVELOPMENT, LLC

City/State/Country

Draper, UT, US

Establishment Address

427 W 11950 S, Draper, UT 84020, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Wasatch Product Development LLC (Owner Number: 10055790)

Owner / Operator Contact Address

427 West 11950 South, Draper, UT 84020, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Conductive Gel Necessaire The Sex Gel McCord Bioclense McCord Biorelese

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GYB	Media, Electroconductive	Neurology	Class 2	882.1275	2021-12-10
NUC	Lubricant, Personal	Obstetrics/Gynecology	Class 2	884.5300	2020-02-27
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2017-10-06

Official Correspondent

Laura Borja

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Wasatch Product Development LLC

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K050212	Qualis, Inc.	PERSONAL WARMING JELLY	2005-03-17

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003676119. Last updated year: 2026. Please use registration number 3003676119 when referencing this establishment in official correspondence.