FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756954421
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
89-9945
Catalog number
89-9945
Device description
FOOT PACK
Published
2021-05-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LROGeneral surgery tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756954421PackageGS13In Commercial Distribution
00749756954426PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975695442150749756954421
00749756954426007497569544267497569544260749756954426

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)938-7828udisupport@deroyal.com

Regulatory Flags#

DUNS number
096372255
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00749756402989DeRoyalNP-0250UNP-0250U2026-09-30
00749756402996DeRoyalNP-0450UNP-0450U2026-09-30
00749756403009DeRoyalNP-0450UNNP-0450UN2026-09-30
00749756403016DeRoyalNP-0250UNNP-0250UN2026-09-30
00749756403023DeRoyalNP-0250U-01NP-0250U-012026-09-30
00749756403375DeRoyal31-120P31-120P2026-09-30
00749756369640DeRoyalNP-7000NP-70002026-09-23
00749756389181DeRoyal81-1020SU81-1020SU2026-09-21
00749756389204DeRoyal81-1020REF81-1020REF2026-09-21
00749756399258DeRoyal46-326XBNS46-326XBNS2026-09-21
00749756400442DeRoyal77-40111877-4011182026-09-21
00749756985475DeRoyalNP-790NP-7902026-09-21
00749756985963DeRoyalNP-7300-01NP-7300-012026-09-21
00749756985994DeRoyalNP-7300NP-73002026-09-21
00749756986250DeRoyalNP-7300NNP-7300N2026-09-21
00749756394666DeRoyal47-820KG47-820KG2026-09-18
00749756397193DeRoyal47-813KG-0147-813KG-012026-09-18
00749756397339DeRoyal15410002154100022026-09-18
00749756397346DeRoyal15410003154100032026-09-18
00749756400800DeRoyal32-219532-21952026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00815849020917Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.LRO2026-10-06
00815849022768Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.LRO2026-10-06
00815849022775Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.LRO2026-10-06
00815849022782Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.LRO2026-10-06
00815849022836Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.LRO2026-10-06
00815849025288Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.LRO2026-10-06
00815849025493Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.LRO2026-10-06
00815849025844Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.LRO2026-10-06
10198956371019CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956474987CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956504172CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956518629CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956520080CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956534520CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956535237CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956538375CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956539761CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956547322CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956549982CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956554016CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956555570CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956561281CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956565838CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956569959CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956570849CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956575035CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956575288CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956582842CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956583061CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06
10198956586482CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-06