Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2184066

FEI Number

1000115761

Entity Name

MASTEL SURGICAL INC.

City/State/Country

RAPID CITY, SD, US

Establishment Address

1550 Samco Rd, RAPID CITY, SD 57702, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Repack or Relabel Medical Device

Owner / Operator

MASTEL SURGICAL INC. (Owner Number: 9005641)

Owner / Operator Contact Address

1550 SAMCO RD, --, Rapid City, SD 57702, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SteriBest Sterilization Tray; Mesh Tray Latch Accessory For Instrument Tray K-WIRE RACK

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2025-07-07
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2025-09-22

Official Correspondent

Steve Sharpless

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-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.
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.

Similar Registrations

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3002669946	Owens & Minor Distribution Inc. OM45	Sunrise, FL, US
1646747	WEXLER SURGICAL, INC.	HOUSTON, TX, US
1037577	ANGIOSYSTEMS, INC.	DUCKTOWN, TN, US
3016171961	HANGZHOU ALLINE PLASTIC CO., LTD.	HANGZHOU Zhejiang, CN
3007485169	MEDYSSEY CO., LTD.	Jecheon-si Chungbuk, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2184066. Last updated year: 2026. Please use registration number 2184066 when referencing this establishment in official correspondence.