Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003440305

FEI Number

3003440305

Entity Name

ISOAID, L.L.C.

City/State/Country

PORT RICHEY, FL, US

Establishment Address

7824 CLARK MOODY BLVD., PORT RICHEY, FL 34668, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ISOAID, L.L.C. (Owner Number: 9048520)

Owner / Operator Contact Address

7824 Clark Moody Blvd, --, Port Richey, FL 34668, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K141701

PMA Number

N/A

All Registered Proprietary Names

Advantage Advantage Advantage Advantage Advantage Advantage

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KXK	Source, Brachytherapy, Radionuclide	Radiology	Class 2	892.5730	2008-01-04
KXK	Source, Brachytherapy, Radionuclide	Radiology	Class 2	892.5730	2001-11-23
KXK	Source, Brachytherapy, Radionuclide	Radiology	Class 2	892.5730	2009-10-26
IWJ	System, Applicator, Radionuclide, Manual	Radiology	Class 1	892.5650	2013-02-14
KXK	Source, Brachytherapy, Radionuclide	Radiology	Class 2	892.5730	2012-01-30
KXK	Source, Brachytherapy, Radionuclide	Radiology	Class 2	892.5730	2014-12-13

Official Correspondent

Timothy Bright

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ISOAID, L.L.C.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K973037	Avid N.I.T., Inc.	N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000	1998-01-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0040-2012	Worldwide Medical Technologies, LLC	1	Prostrate Seeding Applicator Needle. Product code PSS1820AT Packed in boxes of (25) with five Single Packs and four five packs or as singles or five packs. Worldwide Medical Technologies, LLC Used to introduce radionuclide seeds of 1-125 or Pd-103 into the body for radiation therapy. This device is typically used in the transperineal approach for placing radionuclide seeds in the prostate

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3014663932	GT MEDICAL TECHNOLOGIES, INC	Tempe, AZ, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003440305. Last updated year: 2026. Please use registration number 3003440305 when referencing this establishment in official correspondence.