MASTEL SURGICAL INC.

FDA Device Registration & Listing · Schiller Park, IL, US · Registration 3042624965

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
3042624965
FEI Number
3042624965
Entity Name
MASTEL SURGICAL INC.
City/State/Country
Schiller Park, IL, US
Establishment Address
9207 Ivanhoe St, Schiller Park, IL 60176, US
Establishment Type(s)
Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
Mastel Surgical Inc. (Owner Number: 10094842)
Owner / Operator Contact Address
9207 Ivanhoe St, Schiller Park, IL 60176, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

SteriBest Stringer Pouch Rack Latch Accessory For Instrument Tray K-Wire Rack SteriBest Sterilization Tray Mesh tray

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2025-12-29
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2025-12-29
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2025-12-29

Official Correspondent

Ian McKoy

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Mastel Surgical Inc.
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
K881095 CooperVision, Inc. KOI(TM) INSTRUMENT TRAYS 1988-04-06

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0027-2016 Zimmer, Inc. 1
Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0036-2010 Alphatec Spine, Inc. 1
ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042624965. Last updated year: 2026. Please use registration number 3042624965 when referencing this establishment in official correspondence.
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