FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756877985
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
46-4457
Catalog number
46-4457
Device description
Adhesive Remover Wipes 1000/cs
Published
2023-02-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
KOXSOLVENT, ADHESIVE TAPE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOXSolvent, Adhesive TapeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756877980PackageGS11000In Commercial Distribution
00749756877985PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975687798050749756877980
00749756877985007497568779857497568779850749756877985

GMDN Terms#

Term, Definition table
TermDefinition
Skin-cleaning wipe, sterileA sterile device consisting of an absorbent fabric pre-soaked in a liquid solution (e.g. a detergent, alcohol, saline) intended for cleaning a localized body surface before a procedure or device application, and/or to maintain skin hygiene. It is commonly known as a wet wipe and is intended for use in the home or healthcare facility. 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
00749756402699DeRoyal25-1104EU25-1104EU2026-07-22
00749756402705DeRoyal25-1104EUN25-1104EUN2026-07-22
00749756402750DeRoyal25-1401YEU25-1401YEU2026-07-22
00749756402767DeRoyal25-1403EU25-1403EU2026-07-22
00749756402781DeRoyal25-1702EU25-1702EU2026-07-22
00749756402798DeRoyal25-1702EUN25-1702EUN2026-07-22
00749756402910DeRoyal25-0403EUN25-0403EUN2026-07-22
00749756402545DeRoyal25-0103EU25-0103EU2026-07-08
00749756402552DeRoyal25-0103EUN25-0103EUN2026-07-08
00749756402569DeRoyal25-0104EU25-0104EU2026-07-08
00749756402576DeRoyal25-0104EUN25-0104EUN2026-07-08
00749756402583DeRoyal25-0105EU25-0105EU2026-07-08
00749756402590DeRoyal25-0108EU25-0108EU2026-07-08
00749756402606DeRoyal25-0201EU25-0201EU2026-07-08
00749756402613DeRoyal25-0401EU25-0401EU2026-07-08
00749756402620DeRoyal25-0401EUN25-0401EUN2026-07-08
00749756402637DeRoyal25-0402EU25-0402EU2026-07-08
00749756402644DeRoyal25-0402EUN25-0402EUN2026-07-08
00749756402651DeRoyal25-0403EU25-0403EU2026-07-08
00749756402675DeRoyal25-0801EU25-0801EU2026-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30197344179811MEDLINEMEDLINE INDUSTRIES, INC.KOX2026-05-15
08904428744992OSSEOUS-Cleaning PadEON MEDITECH PRIVATE LIMITEDKOX2026-03-13
08904428745012OSSEOUS- Adhesion Remover PadEON MEDITECH PRIVATE LIMITEDKOX2026-03-13
08904428798469OSSEOUS-Cleaning PadEON MEDITECH PRIVATE LIMITEDKOX2026-03-13
08904428799749OSSEOUS- Adhesion Remover PadEON MEDITECH PRIVATE LIMITEDKOX2026-03-13
307073877738793M™3M COMPANYKOX2026-02-19
007073875674603M™3M COMPANYKOX2026-02-19
507073875674653M™3M COMPANYKOX2026-02-19
507073877738733M™3M COMPANYKOX2026-02-19
30080196771763MEDLINEMEDLINE INDUSTRIES, INC.KOX2025-05-07
40080196771760MEDLINEMEDLINE INDUSTRIES, INC.KOX2025-05-07
00840270610062MaxtapingOppo Medical Inc.KOX2025-04-01
00840270610369MaxtapingOppo Medical Inc.KOX2025-04-01
00840270610512MaxtapingOppo Medical Inc.KOX2025-04-01
00840270610529MaxtapingOppo Medical Inc.KOX2025-04-01
06950715505625cofoeCofoe Medical Technology Co.,LtdKOX2024-12-09
00810113577784ViveCareVIVE HEALTH LLCKOX2024-09-04
00810113577791ViveCareVIVE HEALTH LLCKOX2024-09-04
10810113577781ViveCareVIVE HEALTH LLCKOX2024-09-04
10810113577798ViveCareVIVE HEALTH LLCKOX2024-09-04
10193489131550MEDLINEMEDLINE INDUSTRIES, INC.KOX2024-07-04
20193489131557MEDLINEMEDLINE INDUSTRIES, INC.KOX2024-07-04
00810049490676Skinister MedicalDelta Molding LLCKOX2024-05-14
00810049490706Skinister MedicalDelta Molding LLCKOX2024-05-14
10884521738362ANS MEDICALCardinal Health, Inc.KOX2023-05-17
60884521738367ANS MEDICALCardinal Health, Inc.KOX2023-05-17
00850048477063WarriorNPWarriornp LLCKOX2023-03-03
00815991024771BodyMedBOXOUT, LLCKOX2023-02-17
00749756877978DeRoyalDEROYAL INDUSTRIES, INC.KOX2023-02-02
50749756877973DeRoyalDEROYAL INDUSTRIES, INC.KOX2023-02-02