Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022754162

FEI Number

3002754162

Entity Name

PURE SOURCE, LLC

City/State/Country

Doral, FL, US

Establishment Address

9750 NW 17th St, Doral, FL 33172, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

PURE SOURCE, LLC (Owner Number: 10047786)

Owner / Operator Contact Address

9750 NW 17th Street, Doral, FL 33172, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Scarcin Gel Scarcin Roll On VeriCyn Wound Wash Love Lotion Dressing wound hydrogel w/ out and or/ biologic Granu-L8

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2018-08-31
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2025-12-18
NUC	Lubricant, Personal	Obstetrics/Gynecology	Class 2	884.5300	2018-11-19
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2016-02-18
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2025-12-01

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PURE SOURCE, LLC

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
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
K050212	Qualis, Inc.	PERSONAL WARMING JELLY	2005-03-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

Similar Registrations

Registration Number	Establishment Name	Location
2950792	BIODERMIS LLC	Henderson, NV, US
3043138901	DONGGUAN SAMVO BIOTECHNOLOGY CO., LTD	Dongguan Guangdong, CN
3009192857	Neodyne Biosciences, Inc.	Fremont, CA, US
3005857283	PRECO, LLC	Somerset, WI, US
3019769561	ScarPro NV	Aalter Flanders, BE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022754162. Last updated year: 2026. Please use registration number 3022754162 when referencing this establishment in official correspondence.