STERI SOLUTIONS (PTY) LTD

FDA Device Registration & Listing · Midrand Gauteng, ZA · Registration 3043521642

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
3043521642
FEI Number
3043521642
Entity Name
STERI SOLUTIONS (PTY) LTD
City/State/Country
Midrand Gauteng, ZA
Establishment Address
No 106,16th Road, Midrand Gauteng 1686, ZA
Establishment Type(s)
Sterilize Medical Device for Another Party (Contract Sterilizer)
Owner / Operator
STERI SOLUTIONS (PTY) LTD (Owner Number: 10095182)
Owner / Operator Contact Address
No 106,16th Road, Midrand, ZA-GT 1686, ZA
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GAD Retractor General, Plastic Surgery Class 1 878.4800 2026-02-23

Official Correspondent

William Kinnear

US Agent Details

Kimberly Hernandez Business: Wexler Surgical INC. Email: FDA@WexlerSurgical.com Phone: (713) 7236900

Related Public Records

Same Entity

STERI SOLUTIONS (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
K922626 Andronic Devices, Ltd. ADEPT INSTRUMENT POSITIONING ACCESSORY 1992-10-19
K820290 The Anspach Effort, Inc. SELF RETAINING RETRACTOR FOR HAND SURG 1982-03-05
K760422 Cutter Laboratories, Inc. SURGICAL RETRACTOR 1976-08-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-2014 Aesculap, Inc. 1
UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.

Similar Registrations

Registration Number Establishment Name Location
3011050528 FREEHOLD SURGICAL, INC. New Hope, PA, US
3021006167 KIMS MED CO., LTD. Gwangju, KR
3045009502 WISDOM MEDICAL TECHNOLOGY (SHANGHAI) CO., LTD Shanghai, CN
3032847175 BIOPHYX SURGICAL, INC. Edgewater, MD, US
9681129 BEMA-GMBH & CO. KG EMMINGEN Baden-Wurttemberg, DE
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043521642. Last updated year: 2026. Please use registration number 3043521642 when referencing this establishment in official correspondence.
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