Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016628950

FEI Number

3016628950

Entity Name

BALUSTER LLC

City/State/Country

Mountain View, AR, US

Establishment Address

408 Ironworks Drive, Mountain View, AR 72560, US

Establishment Type(s)

Reprocess Single-Use Device,Repack or Relabel Medical Device

Owner / Operator

Baluster LLC (Owner Number: 10073622)

Owner / Operator Contact Address

408 Ironworks Drive, Mountain View, AR 72560, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Baluster Medical

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2023-07-26

Official Correspondent

Caitlin Baker

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Baluster LLC

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 3016628950. Last updated year: 2026. Please use registration number 3016628950 when referencing this establishment in official correspondence.