Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1057404

FEI Number

1000208576

Entity Name

DeRoyal Industries, Inc.

City/State/Country

POWELL, TN, US

Establishment Address

300 DEBUSK LN., POWELL, TN 37849, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

DEROYAL INDUSTRIES, INC. (Owner Number: 1044833)

Owner / Operator Contact Address

200 DEBUSK LN., --, Powell, TN 37849, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Amniotome - DeRoyal Tray, Surgical, Instrument - DeRoyal Bottle, Collection, Vacuum - DeRoyal Orthosis, Limb Brace - DeRoyal Dispenser, Liquid Medication - DeRoyal Accessory, Surgical Apparel - DeRoyal Container, Liquid Medication, Graduated - DeRoyal Caliper, Ophthalmic - DeRoyal Basin, Emesis - DeRoyal Device, Occlusion, Umbilical - DeRoyal Tray, Surgical - DeRoyal Tubing/Tubing with Filter, Insufflation, Laparoscopic - DeRoyal

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HGE	Amniotome	Obstetrics/Gynecology	Class 1	884.4530	2001-08-03
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2001-05-16
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2004-10-19
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2006-06-20
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2005-08-25
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2005-08-25
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2006-08-22
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2012-09-25
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2001-05-16
FOD	Device, Occlusion, Umbilical	General Hospital	Class 1	880.5950	1997-02-12
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2001-02-06
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2009-08-21

Official Correspondent

Elizabeth Reed

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DEROYAL INDUSTRIES, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3008583452	DeRoyal Industries, Inc.	Powell, TN, US
1051550	DEROYAL INDUSTRIES, INC.	MAYNARDVILLE, TN, US
1034876	DEROYAL INDUSTRIES, INC.	MAYNARDVILLE, TN, US
3021190810	DePre, LLC	Powell, TN, US
1055236	DEROYAL INDUSTRIES, INC.	NEW TAZEWELL, TN, US

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.

Similar Registrations

Registration Number	Establishment Name	Location
3014579161	WORLDWIDE SUPPLIES LIMITED	Hong Kong, HK
1054241	DeRoyal Industries, Inc.	NEW TAZEWELL, TN, US
9680254	JIANGSU SUYUN MEDICAL MATERIALS CO., LTD.	LIANYUNGANG, JIANGSU, CN
3030446844	PLATINUM FOCUS GROUP LTD.	London London, City of, GB
3018762668	PLASTI-MED PLASTIK MEDIKAL URUNLER SAN. VE TIC. LTD. STI.	Tuzla Istanbul, TR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1057404. Last updated year: 2026. Please use registration number 1057404 when referencing this establishment in official correspondence.