RhinAer Stylus
Basic Information
- Brand Name
- RhinAer Stylus
- Primary DI
- 08886479300184
- Version / Model
- FG815
- Catalog Number
- CAT821
- Company Name
- Aerin Medical Inc.
- Labeler DUNS
- 051512253
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-03
- Public Version
- 3
- Public Version Date
- 2023-04-21
- Public Version Status
- Update
- Public Device Record Key
- aaac3343-a8ad-47b9-b61f-917f9bceb324
Device Description
The RhinAer Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue. The RhinAer Stylus consists of a handle, shaft and treatment tip. An array of bipolar electrodes is positioned on a non-conductive tip which is attached to a handle via a non-conductive shaft. A temperature sensor is located on the tip to monitor tissue temperature. The Stylus is attached to a temperature-controlled radiofrequency generator via a flexible cable. The RhinAer Stylus treats symptoms of chronic rhinitis by modifying the tissues of the nasal airway through the use of low doses of radiofrequency energy to destroy tissue in the posterior nasal nerve regions. The low-power radiofrequency energy generates heat within the submucosal tissue, destroying local tissue, mucous cells, and glands, and creating a coagulation lesion. This destruction of tissue in posterior nasal nerve regions improves symptoms of chronic rhinitis. The RhinAer Stylus tip is temporarily inserted into the nose to access the treatment area. The procedure requires local anesthesia only.
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44776 | Electrosurgical system | An assembly of devices intended to generate, and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system). The assembly includes a mains electricity-powered (AC-powered) RF generator with monitoring functions/controls, connection cables, a handpiece, and electrodes to apply the energy to the surgical site. Tissue resistance to the electrical current creates the heat as the current travels through the body between electrodes; it is not intended for inert gas-enhanced electrosurgery. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08886479300184 | GS1 |
Customer Contacts
- Phone
- 8334848237
- [email protected]