FDA.report

DeRoyal

Primary DI
30749756646629
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
46-DN88
Catalog number
46-DN88
Device description
Dermanet Ag 8 x 8 (20cm x 20cm)
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
true

Related Records

Product Codes

CodeName
FRODressing, wound, drug

Product Code Classifications

CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30749756646629PackageGS15In Commercial Distribution
50749756646623PackageGS15In Commercial Distribution
00749756646628PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
3074975664662930749756646629
5074975664662350749756646623
00749756646628007497566466287497566466280749756646628

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
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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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