FDA.report

DeRoyal

Primary DI
30749756046207
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
46-710
Catalog number
46-710
Device description
Multidex Gel
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

Related Records

Product Codes

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

Product Code Classifications

CodeDeviceSpecialtyClass
MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or BiologicUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30749756046207PackageGS110In Commercial Distribution
50749756046201PackageGS13In Commercial Distribution
00749756046206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
3074975604620730749756046207
5074975604620150749756046201
00749756046206007497560462067497560462060749756046206

GMDN Terms

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

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
false
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 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

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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
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00383160000029Dash TopicAIM MEDICAL INC.MGQ2024-08-09
00383160000098Dash TopicAIM MEDICAL INC.MGQ2024-08-09
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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