FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756577496
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
47-709
Catalog number
47-709
Device description
ST DRESSING CHANGE KIT
Published
2023-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OXQDressing change tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OXQDressing Change TrayGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756577491PackageGS150In Commercial Distribution
00749756577496PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975657749150749756577491
00749756577496007497565774967497565774960749756577496

GMDN Terms#

Term, Definition table
TermDefinition
Wound dressing kit, medicatedA collection of instruments, dressings, and pharmaceuticals intended to be used to dress a wound. Items typically include scissors, forceps, gauze, cotton-tip applicators, and antiseptics. This is a single-use device.

Regulatory Flags#

DUNS number
096372255
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00749756402545DeRoyal25-0103EU25-0103EU2026-07-08
00749756402552DeRoyal25-0103EUN25-0103EUN2026-07-08
00749756402569DeRoyal25-0104EU25-0104EU2026-07-08
00749756402576DeRoyal25-0104EUN25-0104EUN2026-07-08
00749756402583DeRoyal25-0105EU25-0105EU2026-07-08
00749756402590DeRoyal25-0108EU25-0108EU2026-07-08
00749756402606DeRoyal25-0201EU25-0201EU2026-07-08
00749756402613DeRoyal25-0401EU25-0401EU2026-07-08
00749756402620DeRoyal25-0401EUN25-0401EUN2026-07-08
00749756402637DeRoyal25-0402EU25-0402EU2026-07-08
00749756402644DeRoyal25-0402EUN25-0402EUN2026-07-08
00749756402651DeRoyal25-0403EU25-0403EU2026-07-08
00749756402675DeRoyal25-0801EU25-0801EU2026-07-08
00749756402682DeRoyal25-0802EU25-0802EU2026-07-08
00749756402712DeRoyal25-1108EU25-1108EU2026-07-08
00749756402729DeRoyal25-1108EUN25-1108EUN2026-07-08
00749756402736DeRoyal25-1401EU25-1401EU2026-07-08
00749756402743DeRoyal25-1401EUN25-1401EUN2026-07-08
00749756402774DeRoyal25-1403EUN25-1403EUN2026-07-08
00749756402538DeRoyal25-0101EUN25-0101EUN2026-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956481312CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-07-09
10198956518995CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-07-09
10198956519176CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-07-09
10809160526866MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.OXQ2026-07-08
10198956520233CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-07-06
10198956520547CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-07-06
10198956481282CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-06-23
10198956481305CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-06-23
10653160394037MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-06-22
10653160393764MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-06-10
10653160393849MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-06-10
10198956477278CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-06-08
10198956487765CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-06-05
10198956428942CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-06-01
10198956476639CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-06-01
10198956479852CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-06-01
10653160393726MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-05-27
10653160393733MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-05-27
10193489111224MEDLINEMEDLINE INDUSTRIES, INC.OXQ2022-08-04
10193489190106MEDLINEMEDLINE INDUSTRIES, INC.OXQ2022-01-01
10193489190113MEDLINEMEDLINE INDUSTRIES, INC.OXQ2022-01-01
10193489190120MEDLINEMEDLINE INDUSTRIES, INC.OXQ2022-01-01
10193489190151MEDLINEMEDLINE INDUSTRIES, INC.OXQ2022-01-01
10193489190397MEDLINEMEDLINE INDUSTRIES, INC.OXQ2022-01-01
10193489112689MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-11-01
10193489112528MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-25
10193489112597MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-25
10193489112603MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-25
10193489112610MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-25
10193489112627MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-25