SteriGear, LLC

FDA Device Registration & Listing · Santaquin, UT, US · Registration 3007608536

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
3007608536
FEI Number
3007608536
Entity Name
SteriGear, LLC
City/State/Country
Santaquin, UT, US
Establishment Address
580 W Main St., Santaquin, UT 84655, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
SteriGear, LLC (Owner Number: 10029337)
Owner / Operator Contact Address
362 South University Ave, Provo, UT 84601, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

The Fig Leaf

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FCN Urinary Drainage Collection Kit, For Indwelling Catheter Gastroenterology, Urology Class 2 876.5250 2009-05-04

Official Correspondent

Earl Christensen

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SteriGear, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007608536. Last updated year: 2026. Please use registration number 3007608536 when referencing this establishment in official correspondence.
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