Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8044046

FEI Number

3010598187

Entity Name

BURNSHIELD (PTY) LTD.

City/State/Country

Wadeville Gauteng, ZA

Establishment Address

1 Manchester Road, Medopark Block 3, Wadeville Gauteng 1428, ZA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Burnshield (Pty) Ltd. (Owner Number: 9052084)

Owner / Operator Contact Address

1 Manchester Road, Medopark Block 3, Wadeville, ZA-NOTA 1428, ZA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K921471

PMA Number

N/A

All Registered Proprietary Names

BURNSOOTHE, MEDIBURN, BURNFREE, BURNEEZE, BURNSHIELD HYDROGEL BURN BLOTS Be Smart Get Prepared Everone ARAMARK BURNSHIELD BURNEEZE, BURNFREE, MEDIBURN, BURNSOOTHE, HYDROGEL BURN BLOTS BURNSHIELD Be Smart Get Prepared Everone ARAMARK BURNSHIELD

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MGQ	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic	Unknown	Class U	N/A	2008-04-17
FPY	Sheet, Burn	General Hospital	Class 1	880.5180	2025-11-17
MGQ	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic	Unknown	Class U	N/A	2008-04-17
FPY	Sheet, Burn	General Hospital	Class 1	880.5180	2025-11-17

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Burnshield (Pty) Ltd.

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
K954741	Derma Sciences, Inc.	DERMAGRAN WENT DRESSING (DEXTROSE-SALINE)	1995-11-01

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-05	DeRoyal Wound Care	U	Aquasorb Border, Hydrogel Wound Dressing with Polyurethane Film Border, 25 individual packets per case, Catalog # 46-511, 2.5' x 2.5', labeled in part *SterileManufacturer: DeRoyal 200 Debusk Lane Powell, TN 37849 USA**

Similar Registrations

Registration Number	Establishment Name	Location
3024971708	Carowinds	Charlotte, NC, US
1043214	DEROYAL INDUSTRIES, INC.	POWELL, TN, US
9680091	DERMA SCIENCES CANADA, INC (dba DERMA SCIENCES, INC.)	TORONTO Ontario, CA
1058584	Sterigenics US LLC	Charlotte, NC, US
1921846	Cardinal Health	Hazelwood, MO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8044046. Last updated year: 2026. Please use registration number 8044046 when referencing this establishment in official correspondence.