FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756032636
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
10-1824
Catalog number
10-1824
Device description
Cellulose Burn Pad 23PLY
Published
2023-01-30
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
FPYSHEET, BURN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPYSheet, BurnGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756032631PackageGS136In Commercial Distribution
00749756032636PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975603263150749756032631
00749756032636007497560326367497560326360749756032636

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, permeable, non-antimicrobialA wound covering typically in the form of a porous material (e.g., a fine mesh) impregnated/coated with a substance (e.g., petrolatum, silicone) or made of a material that prevents adherence to the wound bed, thereby decreasing the potential for trauma to the wound and surrounding skin upon removal; it does not contain an antimicrobial agent. Its pores permit the drainage of exudates from, and application of medication to, the wound. It may be used with other wound-care products for chronic and postoperative wounds, burns, skin graft fixation/cultured-cell carrier, cuts, or abrasions; it is neither a dedicated burn dressing nor gauze. This is a single-use device.

Regulatory Flags#

DUNS number
096372255
Device count
1
Premarket exempt
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
M689HHTWBC020TACWrap Multi-Purpose Burn CravatSafeguard US Operating, LLCFPY2026-07-28
M689HHTWBC25010TACWrap Multi-Purpose Burn Cravat Case of 25Safeguard US Operating, LLCFPY2026-07-28
10080196756544MEDLINEMEDLINE INDUSTRIES, INC.FPY2025-10-22
20197344112262MEDLINEMEDLINE INDUSTRIES, INC.FPY2024-11-08
10197344112265MEDLINEMEDLINE INDUSTRIES, INC.FPY2024-11-08
00743537000067First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000074First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000081First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000128First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000135First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000166First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000197First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000203First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537001439First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000029MilitaryWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000036First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000043First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000517First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000111MilitaryWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000531First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000548First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000555First ResponderWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-25
00743537000050BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-19
00743537000005BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-17
00743537000012BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.FPY2024-10-17
10850053289528SURGYCOSurgyco LLCFPY2024-08-09
10850053289597SURGYCOSurgyco LLCFPY2024-08-09
10850053289603SURGYCOSurgyco LLCFPY2024-08-09
10850053289610SURGYCOSurgyco LLCFPY2024-08-09
00850053289521SURGYCOSurgyco LLCFPY2024-08-09