FDA UDI
In Commercial Distribution
🇺🇸 United States
OSSEOUS
DI: 08906039319392
·
Model: E31031
·
EON MEDITECH PRIVATE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- OSSEOUS
- Primary DI
- 08906039319392
- Version / Model
- E31031
- Company Name
- EON MEDITECH PRIVATE LIMITED
- Labeler DUNS
- 930270428
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-13
- Public Version
- 1
- Public Version Date
- 2024-05-21
- Public Version Status
- New
- Public Device Record Key
- fda8598e-115e-4755-8daf-7d4a8c8b014b
Device Description
Epistaxis Balloon Catheter is designed for fast control of intra-nasal bleeding and patient comfort. Ideal for nasal packing for Septoplastly, Rhinoplastly and Intra-nasal surgical procedure. Inflatable flexible balloon provides direct uniform pressure. Beveled posterior tip & soft silicone construction allow for easy placement & prevents adhesion for easy removal. Airway channel design allows nasal breathing.
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 |
|---|---|---|---|---|
| EMX | Balloon, Epistaxis | Ear, Nose, Throat | 874.4100 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12699 | Nasal haemostatic balloon | A device consisting of a hollow rubber or rubber-like structure, expandable with either liquid or air, intended to be used to control nose bleeding (epistaxis) of the anterior or posterior nasal cavity. It is applied during an ear/nose/throat (ENT) intervention and can also be used to treat glue ear in children, and/or to support the structure and patency of the nasal canal. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08906039312447 | GS1 | Laminated Box | 10 | In Commercial Distribution | |
| Primary | 08906039319392 | GS1 | ||||
| Package | 08904461000031 | GS1 | Laminated Box | 1 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Working Length | 160 | Millimeter | |
| Balloon Diameter | 34 | Millimeter | |
| Balloon Length | 30 | Millimeter | |
| Balloon Diameter | 22 | Millimeter | |
| Balloon Length | 22 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 25 Degrees Celsius