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OSSEOUS
EON MEDITECH PRIVATE LIMITED · Model E31010 · UDI-DI 08906039319385
EMX
Prescription
10
510(k) clearances
102
Adverse events (2 deaths)
4
Recalls
53
Facilities
Description
Epistaxis Balloon Catheter is designed for fast control of intra-nasal bleeding and patient comfort. Ideal for nasal packing for Septoplasty, 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.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2003-01-08 | Ultracell Medical Technologies | Sterility of the device is compromised |
| 2003-01-08 | Ultracell Medical Technologies | Sterility of the device is compromised |
| 2003-01-08 | Ultracell Medical Technologies | Sterility of the device is compromised |
| 2003-01-08 | Ultracell Medical Technologies | Sterility of the device is compromised |
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