FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756032773
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
10-2824
Catalog number
10-2824
Device description
Cellulose Burn Pad 15 PLY
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
50749756032778PackageGS115In Commercial Distribution
00749756032773PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975603277850749756032778
00749756032773007497560327737497560327730749756032773

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
00749756401944DeRoyal46-LT5S-0546-LT5S-052026-05-14
00749756998857DeRoyal99-021399-02132019-11-09
00749756998864DeRoyal99-021499-02142019-11-09
00749756998871DeRoyal99-021599-02152019-11-09
00749756998888DeRoyal99-021699-02162019-11-09
00749756998901DeRoyal99-021799-02172019-11-09
00749756998918DeRoyal99-021899-02182019-11-09
00749756998925DeRoyal99-021999-02192019-11-09
00749756998956DeRoyal99-022099-02202019-11-09
00749756998963DeRoyal99-022199-02212019-11-09
00749756998970DeRoyal99-022299-02222019-11-09
00749756998642DeRoyal99-021199-02112021-05-07
00749756401685DeRoyalNP-7DAYKITUTSNP-7DAYKITUTS2026-04-02
00749756401951DeRoyal46-LT20S-0446-LT20S-042026-04-02
00749756401968DeRoyal46-LT19S-0446-LT19S-042026-04-02
00749756402033DeRoyal46-LB5546-LB552026-04-02
00749756879699DeRoyal1104SPP1104SPP2026-04-02
00749756879705DeRoyal1104MPP1104MPP2026-04-02
00749756879712DeRoyal1104LPP1104LPP2026-04-02
00749756879729DeRoyal1104XLPP1104XLPP2026-04-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00850053289590SURGYCOSurgyco LLCFPY2024-08-09
00850053289606SURGYCOSurgyco LLCFPY2024-08-09