FDA UDI
In Commercial Distribution
🇺🇸 United States
OSSEOUS
DI: 08906039312034
·
Model: E3131608
·
EON MEDITECH PRIVATE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- OSSEOUS
- Primary DI
- 08906039312034
- Version / Model
- E3131608
- Company Name
- EON MEDITECH PRIVATE LIMITED
- Labeler DUNS
- 930270428
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-12
- Public Version
- 1
- Public Version Date
- 2024-06-20
- Public Version Status
- New
- Public Device Record Key
- 755590b6-9f41-423e-8bfd-bf8b097a6d1b
Device Description
Laryngectomy Button is a self-retaining holder for device in the intended for vocal and pulmonary rehabilitation after Laryngectomy. It can supply stomal support and help to keep the tracheostoma open.
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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KAC | Tube, Laryngectomy | Ear, Nose, Throat | 874.4420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 14093 | Tracheostoma button | A hollow device intended to be used routinely by a patient to prevent the narrowing of a tracheostoma during intermittent use of their tracheostomy or laryngectomy tube. It is a cylindrical synthetic polymer device designed for minimal intrusion beyond the tracheostomal orifice into which it is placed. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08906039314496 | GS1 | Laminated Box | 1 | In Commercial Distribution | |
| Primary | 08906039312034 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 8 | Millimeter | |
| Outer Diameter | 16 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 25 Degrees Celsius