Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042616749

FEI Number

3042616749

Entity Name

INJECTA MEDICAL LLC

City/State/Country

Hialeah, FL, US

Establishment Address

19701 W Oakmont Dr, Hialeah, FL 33015, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

INJECTA MEDICAL LLC (Owner Number: 10094511)

Owner / Operator Contact Address

19701 W Oakmont Dr, Hialeah, FL 33015, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Injecta MBB Procedural Delivery System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2025-12-04

Official Correspondent

David Pires-Garnicki

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

INJECTA MEDICAL 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 3042616749. Last updated year: 2026. Please use registration number 3042616749 when referencing this establishment in official correspondence.