Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010039499

FEI Number

3010039499

Entity Name

Cirtec Medical

City/State/Country

Rock Hill, SC, US

Establishment Address

663 Bryant Blvd., Rock Hill, SC 29732, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Cirtec Medical (Owner Number: 10042767)

Owner / Operator Contact Address

663 Bryant Blvd, Rock Hill, SC 29732, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sterrad Instrument Tray Holder

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	2013-01-10

Official Correspondent

Shay Holland

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Cirtec Medical

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.

Similar Registrations

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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 3010039499. Last updated year: 2026. Please use registration number 3010039499 when referencing this establishment in official correspondence.