FDA.reportPublic FDA data

OSSEOUS- Adhesion Remover Pad

Primary DI
08904428745012
Brand
OSSEOUS- Adhesion Remover Pad
Company
EON MEDITECH PRIVATE LIMITED
Model
EA91063
Device description
The Adhesive removal pad are single use tracheostomy pads that provide protection between the tracheal cannula and the skin and absorb secretions. It enlarges during use. If due to this it slips off the tube or tears easily it is worn out and needs to be replaced. Helps to remove an adhesive. Alcohol-free and removes adhesive and adhesive residue easily.
Published
2026-03-13
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
08904428799749PackageGS150In Commercial Distribution
08904428745012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08904428799749089044287997498904428799749
08904428745012089044287450128904428745012

GMDN Terms#

Term, Definition table
TermDefinition
Patient medical adhesive removerA liquid solvent intended for removal of medical adhesive/adhered devices (e.g., residual adhesive, adhesive tape, ostomy devices) from a patient’s skin. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature25 Degrees Celsius0 Degrees Celsius

Regulatory Flags#

DUNS number
930270428
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08904428721399OSSEOUS- Skin Closure TapeEA910662026-03-13
08904428721405OSSEOUS- Skin Preparation PadEA910622026-03-13
08904428744916OSSEOUS- ShowerProtectEA910512026-03-13
08904428744947OSSEOUS- NeckFit Tube HolderEA910532026-03-13
08904428744954OSSEOUS- Tube Cleaning Brush - 8mmEA910712026-03-13
08904428744992OSSEOUS-Cleaning PadEA910612026-03-13
08904428745067OSSEOUS- TouchFree HME Series - StandardEA9100112026-03-13
08904461000499OSSEOUS-Heat Moisture Exchanger-AirEA910012026-03-13
08904461028783OSSEOUS- Shaver Blade Tube E2120-012026-03-13
08904461031080OSSEOUS-Ear/Nasal ExtractorE31492026-03-13
08904461055031OSSEOUS-SnorOFFE317012026-03-13
08904461055697OSSEOUS-CapsuleEA9100182026-03-13
00890446104932OSSEOUS-Endoscrub 4 mm ( 0° )EI29012026-03-13
08904428745326OSSEOUS- Skin Closure TapeEA910662026-03-13
08904428745333OSSEOUS- Skin Preparation PadEA910622026-03-13
08904428798421OSSEOUS- ShowerProtectEA910512026-03-13
08904428798438OSSEOUS- NeckFit Tube HolderEA910532026-03-13
08904428798483OSSEOUS- Tube Cleaning Brush - 8mmEA910712026-03-13
08904428798469OSSEOUS-Cleaning PadEA910612026-03-13
08904428799749OSSEOUS- Adhesion Remover PadEA910632026-03-13

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
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
50749756877973DeRoyalDEROYAL INDUSTRIES, INC.KOX2023-02-02