Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005370013

FEI Number

3005370013

Entity Name

FIRST USE LLC

City/State/Country

LEXINGTON, KY, US

Establishment Address

2500 SANDERSVILLE RD., LEXINGTON, KY 40511, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

FIRST USE LLC (Owner Number: 9077490)

Owner / Operator Contact Address

709 RAINWATER DR., --, Lexington, KY 40515, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

GAYHEART CORNEAL TREPHINE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HRH	Trephine, Manual, Ophthalmic	Ophthalmic	Class 1	886.4350	2005-09-13

Official Correspondent

DHAVAL SHUKLA

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

FIRST USE LLC

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

View Entity Profile →

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1319639	Sterigenics U.S., LLC	Queensbury, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005370013. Last updated year: 2026. Please use registration number 3005370013 when referencing this establishment in official correspondence.