FDA UDI
In Commercial Distribution
🇺🇸 United States
OSSEOUS- Adhesion Remover Pad
DI: 08904428745012
·
Model: EA91063
·
EON MEDITECH PRIVATE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- OSSEOUS- Adhesion Remover Pad
- Primary DI
- 08904428745012
- Version / Model
- EA91063
- Company Name
- EON MEDITECH PRIVATE LIMITED
- Labeler DUNS
- 930270428
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-13
- Public Version
- 1
- Public Version Date
- 2026-03-23
- Public Version Status
- New
- Public Device Record Key
- 13ebef24-fc5e-4edb-87bc-d91a17a477de
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KOX | Solvent, Adhesive Tape | General, Plastic Surgery | 878.4730 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60494 | Patient medical adhesive remover | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08904428799749 | GS1 | Laminated Box | 50 | In Commercial Distribution | |
| Primary | 08904428745012 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 25 – Degrees Celsius