FDA.reportPublic FDA data

DeRoyal

Primary DI
30749756992290
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
46-710-EU
Catalog number
46-710-EU
Device description
Multidex
Published
2023-02-03
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
false

Product Codes#

Code, Name table
CodeName
MGQDressing, wound and burn, hydrogel w/drug and/or biologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or BiologicUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30749756992290PackageGS15In Commercial Distribution
50749756992294PackageGS16In Commercial Distribution
00749756992299PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3074975699229030749756992290
5074975699229450749756992294
00749756992299007497569922997497569922990749756992299

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, permeable, 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, and that contains an antimicrobial agent (e.g., silver (Ag), honey). Its pores permit the drainage of exudates from, and application of medication to, the wound. This device may be used with other wound-care products to help heal chronic/infected and postoperative wounds, burns, skin grafts, cuts, or abrasions; it is not a dedicated burn dressing. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50749756033140DeRoyal10-513010-51302023-01-31
50749756392490DeRoyalNP-6006UNP-6006U2026-01-22
50749756397808DeRoyalNP-0080LMDNP-0080LMD2026-01-22
00749756401258DeRoyalSTM2000STM20002026-01-22
50749756401352DeRoyalM60-AP500M60-AP5002026-01-22
50749756401376DeRoyalM60-AP600M60-AP6002026-01-22
50749756401383DeRoyalM60-AP601M60-AP6012026-01-22
50749756401390DeRoyalM60-AP602M60-AP6022026-01-22
50749756401482DeRoyal46-LT19S-01B46-LT19S-01B2026-01-22
50749756401437DeRoyalM70-200PM70-200P2026-01-01
50749756401444DeRoyalM70-200CM70-200C2026-01-01
50749756401451DeRoyalM70-200CNWM70-200CNW2026-01-01
50749756401468DeRoyalM70-200PNWM70-200PNW2026-01-01
50749756394418DeRoyal71-080571-08052025-08-13
50749756396641DeRoyalPH81-010400PH81-0104002025-08-13
50749756397853DeRoyalPH81-020409PH81-0204092025-08-13
50749756397860DeRoyalPH81-020412PH81-0204122025-08-13
00749756399333DeRoyal1-524A-01-CHO1-524A-01-CHO2025-07-30
00749756399340DeRoyal1-524A-02-CHO1-524A-02-CHO2025-07-30
00749756399357DeRoyal1-524A-03-CHO1-524A-03-CHO2025-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00383160000104Dash TopicAIM MEDICAL INC.MGQ2025-05-12
00850058790084SuprelloGel4med, Inc.MGQ2025-03-25
00860013569907MuGardSoleva Pharma LLCMGQ2025-02-28
00743537000784BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000807BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000821BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000845Burn StopWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000906Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000920Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537001002Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537001040Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537001064Burn StopWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537001088Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000760BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-10-31
00743537001200Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-10-29
00743537001217Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-10-29
00370564456156Gelclair® CONCENTRATED ORAL GELNapo Pharmaceuticals, Inc.MGQ2024-09-13
50192253040102KendallCardinal Health 200, LLCMGQ2024-08-14
50192253040119KendallCardinal Health 200, LLCMGQ2024-08-14
00383160000029Dash TopicAIM MEDICAL INC.MGQ2024-08-09
00383160000098Dash TopicAIM MEDICAL INC.MGQ2024-08-09
10850058655007PeriovanceORABIO, INC.MGQ2024-05-31
20686864060776MedicomAMD Medicom IncMGQ2024-05-08
00383160000012Dash TopicAIM MEDICAL INC.MGQ2024-04-25
50192253040133KendallCardinal Health 200, LLCMGQ2024-04-15
50192253040140KendallCardinal Health 200, LLCMGQ2024-04-15
00358962302008Canker-X Rincinol Mouth Sore RinseAlliance Pharma Inc.MGQ2024-04-05
00358962303005Canker-X Mouth Sore SprayAlliance Pharma Inc.MGQ2024-04-05
00358962301001Canker-X Mouth Sore GelAlliance Pharma Inc.MGQ2024-04-02
00370275713050OrapeuticForward Science Technologies LLCMGQ2024-02-14