Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1034876

FEI Number

1034876

Entity Name

DEROYAL INDUSTRIES, INC.

City/State/Country

MAYNARDVILLE, TN, US

Establishment Address

185 RICHARDSON WAY, MAYNARDVILLE, TN 37807, 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

Bedding Disposable, Medical - DeRoyal Kit, Surgical Instrument, Disposable - DeRoyal Sheet, Burn - DeRoyal Dressing, Wound, Drug - DeRoyal Multidex Restraint, Protective - DeRoyal Splint, Hand, and Components - DeRoyal WRIST Dressing, Wound, Drug - DeRoyal / Dressing, Wound and Burn, Hydrogel w/Drug and/or Biologic - DeRoyal Silver Alginate Cath Patch Dressing - DeRoyal Joint, Ankle, External Brace - DeRoyal Support, Patient Position - DeRoyal Pad, Neonatal Eye - DeRoyal Warmer, Infant Radiant - DeRoyal Device, Transfer, Patient, Manual - DeRoyal Dressing, Wound, Occlusive - DeRoyal Tape, Measuring, Rulers and Calipers - DeRoyal Instrument, Manual, Surgical, General Use - DeRoyal Shield, Eye, Ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear) - DeRoyal Dressing, Wound, Drug - DeRoyal Dressing, Wound, Hydrophilic - DeRoyal Protector, Skin Pressure - DeRoyal Catheter, Continuous Irrigation - DeRoyal Accessory, Surgical Apparel - DeRoyal

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2005-04-14
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2001-08-03
FPY	Sheet, Burn	General Hospital	Class 1	880.5180	2004-12-09
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2010-08-23
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2015-09-15
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2006-06-20
MGQ	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic	Unknown	Class U	N/A	2007-12-28
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2007-12-28
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2005-08-08
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2005-08-08
FOK	Pad, Neonatal Eye	General Hospital	Class 1	880.5270	2001-08-03
FMT	Warmer, Infant Radiant	General Hospital	Class 2	880.5130	2020-08-11
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2018-11-01
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2004-12-09
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2006-08-22
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2006-08-22
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2012-09-25
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2007-12-28
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2004-06-23
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2006-07-27
GBQ	Catheter, Continuous Irrigation	General, Plastic Surgery	Class 1	878.4200	2015-11-09
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2005-08-25

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
1057404	DeRoyal Industries, Inc.	POWELL, 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
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
K962327	Sekure Seat Corp.	SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE	1997-03-06
K963243	Heelbo, Inc.	HEELBO BLAZER SLEEVED JACKET	1996-10-01
K954741	Derma Sciences, Inc.	DERMAGRAN WENT DRESSING (DEXTROSE-SALINE)	1995-11-01
K020219	Replacement Parts Industries, Inc.	RPI SKIN OR AIR TEMPERATURE PROBE	2002-04-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Z-0001-05	DeRoyal Wound Care	U	Aquasorb Border, Hydrogel Wound Dressing with Polyurethane Film Border, 25 individual packets per case, Catalog # 46-511, 2.5' x 2.5', labeled in part *SterileManufacturer: DeRoyal 200 Debusk Lane Powell, TN 37849 USA**
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1034876. Last updated year: 2026. Please use registration number 1034876 when referencing this establishment in official correspondence.