Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012619291

FEI Number

3012619291

Entity Name

BIOTE MEDICAL, LLC

City/State/Country

Irving, TX, US

Establishment Address

1875 W. Walnut Hill Lane Suite 100, Irving, TX 75038, US

Establishment Type(s)

Repack or Relabel Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Biote Medical (Owner Number: 10054949)

Owner / Operator Contact Address

1875 W. Walnut Hill Lane Suite 100, Irving, TX 75038, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BioTE Reusable Trocar BioTE Medical, LLC BioTE Disposable Trocar (Included in Convenience Kit)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2017-05-17

Official Correspondent

Sandy Eichman

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Biote Medical

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 3012619291. Last updated year: 2026. Please use registration number 3012619291 when referencing this establishment in official correspondence.