FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756041003
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
10-930
Catalog number
10-930
Device description
ST. BURN KIT ADULT MEDIUM
Published
2023-02-02
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
OJJBurn kit without drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJJBurn Kit Without DrugGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756041008PackageGS110In Commercial Distribution
00749756041003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975604100850749756041008
00749756041003007497560410037497560410030749756041003

GMDN Terms#

Term, Definition table
TermDefinition
Burn kit, non-medicatedA collection of devices designed to treat first or second degree burns typically as first aid therapy by emergency medical services (EMS); it does not include pharmaceuticals. It typically includes burn dressings, burn gels, gauze, cold packs, adhesive tapes, and gloves; it may include additional devices such as scissors and masks. 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
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
00749756401289DeRoyalNP-7000-GPSNP-7000-GPS2026-09-18
00749756401678DeRoyal13-809A-01-COSM13-809A-01-COSM2026-09-18
00749756401692DeRoyalNP-6007U-01NP-6007U-012026-09-18
00749756401708DeRoyal46-LB19546-LB1952026-09-18
00749756401715DeRoyal46-LB38546-LB3852026-09-18
00749756401739DeRoyalM60-SF510TM60-SF510T2026-09-18
00749756401746DeRoyalNP-120UNP-120U2026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956559257CARDINAL HEALTHCardinal Health 200, LLCOJJ2026-09-04
10198956500099CARDINAL HEALTHCardinal Health 200, LLCOJJ2026-07-31
10198956534018CARDINAL HEALTHCardinal Health 200, LLCOJJ2026-07-27
10198956483804CARDINAL HEALTHCardinal Health 200, LLCOJJ2026-06-01
10194717121831Regard™ROI CPS, LLCOJJ2025-01-28
10195327596453Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2024-07-29
10195327627782Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2024-07-29
10195327627836Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2024-07-29
10195327632724Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2024-07-29
10195327651381Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2024-07-29
10195327655921Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2024-07-29
10195327672584Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2024-04-28
10195327623074Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2024-02-11
10194717118619Regard™ROI CPS, LLCOJJ2024-02-07
10195327578848Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-12-24
10195327494445Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-12-21
10195327494513Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-12-21
10195327548353Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-12-21
10195327523282Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-10-15
10195327523763Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-10-15
10195327513375Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-10-01
10195327471576Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-08-13
10195327443856Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-07-29
10195327376161Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-06-13
10195327409968Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-05-21
10195327328047Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-01-29
10195327328337Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-01-22
10195327328375Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-01-22
10195327320928Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-01-15
10195327325725Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-01-15