FDA.reportPublic FDA data

OSSEOUS- Adhesion Remover Pad

Primary DI
08904428799749
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
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
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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
930270428
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
08904428745012OSSEOUS- Adhesion Remover PadEA910632026-03-13
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810040130465Safe N Simple LLCSAFE N' SIMPLE LLCKOX2026-10-14
00810040130472Safe N Simple LLCSAFE N' SIMPLE LLCKOX2026-10-14
00810040135538Safe N Simple LLCSAFE N' SIMPLE LLCKOX2026-10-14
00850002835199Safe N Simple LLCSAFE N' SIMPLE LLCKOX2026-10-14
00850002835205Safe N Simple LLCSAFE N' SIMPLE LLCKOX2026-10-14
00850002835557Safe N Simple LLCSAFE N' SIMPLE LLCKOX2026-10-14
00850002835564Safe N Simple LLCSAFE N' SIMPLE LLCKOX2026-10-14
00850004779057Safe N Simple LLCSAFE N' SIMPLE LLCKOX2026-10-14
00856253007361Safe N Simple LLCSAFE N' SIMPLE LLCKOX2026-10-14
00856253007378Safe N Simple LLCSAFE N' SIMPLE LLCKOX2026-10-14
00856253007385Safe N Simple LLCSAFE N' SIMPLE LLCKOX2026-10-14
00856253007392Safe N Simple LLCSAFE N' SIMPLE LLCKOX2026-10-14
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
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