Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010452421

FEI Number

3010452421

Entity Name

Ortho and Surgical Products Enterprises S.A.

City/State/Country

Villa Canales Guatemala, GT

Establishment Address

KM 20.5 Carretera a Villa Canales, Zona 3 Finca Morancito,, Villa Canales Guatemala 01065, GT

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

Burn Kit without Drug - DeRoyal Marker, Skin - DeRoyal Bedding Disposable, Medical - DeRoyal Forceps, General & Plastic Surgery - DeRoyal Drape, Surgical, Exempt - DeRoyal Patch, Pledget and Intracardiac, PETP, PTFE, Polypropylene - DeRoyal Gauze/Sponge, Internal, X-Ray Detectable - DeRoyal Tubes, Gastrointestinal (and Accessories) - DeRoyal Device, Fixation, Tracheal Tube - DeRoyal Tourniquet, Nonpneumatic - DeRoyal General Surgery Tray (Kit) - DeRoyal General Surgery Tray - DeRoyal Support, Patient Position - DeRoyal Applicator, Absorbent Tipped, Sterile - DeRoyal Instrument, Surgical, Disposable - DeRoyal Dissector, Surgical, General & Plastic Surgery - DeRoyal Pad, Neonatal Eye - DeRoyal Suture, Nonabsorbable, Silk - DeRoyal Splint, Traction - DeRoyal Stax Gauze/Sponge, Internal - DeRoyal Laparoscope, General & Plastic Surgery - DeRoyal Accessories, Operating-Room, Table (Kit) - DeRoyal Patch, Pledget and Intracardiac, PETP, PTFE, Polypropylene - DeRoyal Walker, Mechanical - DeRoyal Restraint, Wheelchair, Non-Protective - DeRoyal Dressing, Wound, Drug - DeRoyal Applicator, Absorbent Tipped, Non-Sterile - DeRoyal Tape and Bandage, Adhesive - DeRoyal Bed, Ac-Powered Adjustable Hospital - DeRoyal Scissors, General, Surgical - DeRoyal Protector, Skin Pressure - DeRoyal Halter, Head, Traction - DeRoyal Dressing Change Tray - DeRoyal Cover, Limb - DeRoyal Sheet, Burn - DeRoyal Hemostat - DeRoyal Restraint, Protective - DeRoyal Dressing, Wound, Occlusive - DeRoyal Device, Intravascular Catheter Securement - DeRoyal Kit, Surgical Instrument, Disposable - DeRoyal Orthosis, Cervical - DeRoyal Device, Transfer, Patient, Manual - DeRoyal Gauze/Sponge, Nonresorbable for External Use - DeRoyal Dressing, Wound, Hydrophilic - DeRoyal Aid, Transfer - DeRoyal Bandage, Cast - DeRoyal Fiber, Medical, Absorbent - DeRoyal Splint, Hand, and Components - DeRoyal WRIST Bandage, Elastic - DeRoyal Accessories, Traction - DeRoyal Binder, Abdominal - DeRoyal Sling, Arm - DeRoyal Scissors, Medical, Disposable - DeRoyal

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OJJ	Burn Kit Without Drug	General, Plastic Surgery	Class 1	878.4022	2015-12-10
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2006-08-22
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2005-04-14
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2001-08-03
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2017-08-01
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2024-02-19
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2006-08-22
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2025-06-11
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2005-08-08
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2005-09-28
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2016-06-03
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2005-08-08
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2004-06-23
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2001-02-21
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2001-08-03
FOK	Pad, Neonatal Eye	General Hospital	Class 1	880.5270	2001-08-03
GAL	Suture, Absorbable, Natural	General, Plastic Surgery	Class 2	878.4830	2016-01-15
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2016-01-15
GAQ	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	General, Plastic Surgery	Class 2	878.4495	2016-01-15
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2016-01-15
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2016-01-15
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2016-01-15
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2016-01-15
HSP	Splint, Traction	Orthopedic	Class 1	888.5890	1997-01-13
EFQ	Gauze/Sponge, Internal	Unknown	Class U	N/A	2010-01-29
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2009-08-24
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2012-09-28
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2005-08-25
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2012-03-22
KID	Restraint, Wheelchair, Non-Protective	Physical Medicine	Class 1	890.3910	2005-08-08
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2007-12-28
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2001-08-03
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2003-04-04
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2011-07-14
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2004-12-09
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2006-07-27
HSS	Halter, Head, Traction	Orthopedic	Class 1	888.5890	2006-08-09
OXQ	Dressing Change Tray	General Hospital	Class 1	880.5075	2015-12-10
IPM	Cover, Limb	Physical Medicine	Class 1	890.3025	2001-08-03
FPY	Sheet, Burn	General Hospital	Class 1	880.5180	2004-12-09
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2006-08-22
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2015-09-15
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2004-12-09
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2015-09-15
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2001-08-03
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2006-06-20
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2018-11-01
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	1994-01-04
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2004-06-23
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2012-08-27
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2005-08-08
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2006-08-22
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2006-06-20
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2006-08-09
ILZ	Accessories, Traction	Physical Medicine	Class 1	890.5925	2015-09-21
FSD	Binder, Abdominal	General Hospital	Class 1	880.5160	2006-06-20
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2006-07-27
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	1998-08-07

Official Correspondent

Elizabeth Reed

US Agent Details

Elizabeth Reed Business: DeRoyal Industries, Inc. Email: ereed@deroyal.com Phone: (865) 3621256

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
1034876	DEROYAL INDUSTRIES, INC.	MAYNARDVILLE, TN, US
3021190810	DePre, LLC	Powell, TN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28
K790050	Stanford Professional Products	SPONGES, STANFORD STERILE LAP	1979-01-17
K900590	Biosearch Medical Products, Inc.	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	1990-08-02
K102548	Footprint Medical, Inc.	FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE	2010-11-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0028-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0030-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0031-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0095-2021	Alcon Research, LLC	2	Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries.

Similar Registrations

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2320762	DEROYAL INDUSTRIES, INC.	NEW TAZEWELL, TN, US
1928237	MIDWEST STERILIZATION CORP.	JACKSON, MO, US
3035642068	Honduras Kitting, S.A.	Villanueva Cortes, HN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010452421. Last updated year: 2026. Please use registration number 3010452421 when referencing this establishment in official correspondence.