Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014103552

FEI Number

3014103552

Entity Name

GUS GEAR, INC.

City/State/Country

Pittsburgh, PA, US

Establishment Address

100 S Jackson Ave, Pittsburgh, PA 15202, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Gus Gear, Inc. (Owner Number: 10056108)

Owner / Operator Contact Address

6196 Penn Dr, Butler, PA 16002, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Gus Gear Dual Safe Strip Gus Gear Single Safe Strip Gus Gear Central Line Wrap Gus Gear LOCK 3000 Belt Gus Gear Central Line Vest Gus Gear LOCK 2000 Vest

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MDR	Binder, Medical, Therapeutic	General Hospital	Class 1	880.5160	2017-11-07

Official Correspondent

Sarah Palya

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Gus Gear, 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 3014103552. Last updated year: 2026. Please use registration number 3014103552 when referencing this establishment in official correspondence.