BON ROUX (PTY) LTD

FDA Device Registration & Listing · PRETORIA Gauteng, ZA · Registration 3003865243

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003865243
FEI Number
3003865243
Entity Name
BON ROUX (PTY) LTD
City/State/Country
PRETORIA Gauteng, ZA
Establishment Address
695 TETRA AVENUE, MORELETAPARK, PRETORIA Gauteng 0044, ZA
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
BON ROUX (PTY) LTD (Owner Number: 9050392)
Owner / Operator Contact Address
695 TETRA AVENUE, --, MORELETAPARK PRETORIA, ZA-NOTA 0044, ZA
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

OTC - VACURECT Vacuum Constriction Device (RE: K020969) RX - VACURECT Vacuum Constriction Device (RE: K032776)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LKY Device, External Penile Rigidity Gastroenterology, Urology Class 2 876.5020 2004-04-06

Official Correspondent

No official correspondent registered.

US Agent Details

Donald Lechner Business: Mainspring Medical LLC Email: mainspringmedical@gmail.com Phone: (706) 4264145

Related Public Records

Same Entity

BON ROUX (PTY) LTD
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003865243. Last updated year: 2026. Please use registration number 3003865243 when referencing this establishment in official correspondence.
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