FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756877980
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
OTC
false
Sterile
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
096372255
Device count
1
DM exempt
false
Premarket exempt
true
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 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
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
00749756877985DeRoyalDEROYAL INDUSTRIES, INC.KOX2023-02-02