MedtechSourcebook

PURE SOURCE, LLC

Contract manufacturer ยท Doral, FL

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

2016Product codes first listed, by year (tallest: 2)2026
FDA registration
3022754162 (openFDA record; or search FDA's registration database)
FEI number
3002754162
Registered for
FDA registration year 2026
Establishment types
Manufacturer for export only; Contract manufacturer; Repackager or relabeler
Owner or operator
PURE SOURCE, LLC (FDA owner/operator no. 10047786)
Registered address
9750 NW 17th St, Doral, FL 33172
Contract listings
5 device listings, 4 product codes, first listed Feb 18, 2016
Certification
Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product codeDevice (FDA name)ClassCategoryRoleFirst listed
FRODressing, Wound, DrugUnclassifiedGeneral and plastic surgeryContract manufacturingDec 18, 2025
MDAElastomer, Silicone, For Scar ManagementClass IGeneral and plastic surgeryContract manufacturingAug 31, 2018
NAEDressing, Wound, Hydrogel Without Drug And/Or BiologicClass IGeneral and plastic surgeryContract manufacturingFeb 18, 2016
NUCLubricant, PersonalClass IIObstetrics and gynecologyContract manufacturingNov 19, 2018