RhinAer Stylus
- Primary DI
- 08886479300184
- Brand
- RhinAer Stylus
- Company
- Aerin Medical Inc.
- Model
- FG815
- Catalog number
- CAT821
- 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.
- Published
- 2020-02-03
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- true
Contact Domains#
Product Codes#
| Code | Name |
|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 2 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 08886479300184 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 08886479300184 | 08886479300184 | 8886479300184 |
GMDN Terms#
| Term | Definition |
|---|---|
| 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 argon-enhanced electrosurgery. |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| 8334848237 | customerservice@aerinmedical.com |
Regulatory Flags#
- DUNS number
- 051512253
- Device count
- 1
- Lot or batch
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 08886479300306 | RhinAer+ Stylus | FG2258 | CAT2259 | 2025-09-19 |
| 08886479300023 | InSeca ARC Stylus | FG256 | CAT409 | 2017-12-19 |
| 08886479300146 | Vivaer ARC Stylus | FG257 | CAT410 | 2017-12-19 |
| 08886479300160 | VivAer® Stylus | FG722 | CAT723 | 2020-10-19 |
| 08886479300269 | VivAer® Stylus | FG1787 | CAT1785 | 2024-01-05 |
| 08886479300030 | Aerin Console | FG226 | CAT305 | 2017-12-19 |
| 08886479300238 | RhinAer® Stylus | FG1393 | CAT1394 | 2022-08-19 |
| 08886479300047 | Aerin Console Set | CAT305 | CAT305-02 | 2017-12-19 |
| 08886479300283 | Aerin Console | FG2045 | CAT2046 | 2024-12-18 |
| 08886479300290 | Aerin Console Set | FG2045 | CAT2046-01 | 2024-12-18 |
| 08886479300252 | Reach Needle | CAT1614-05 | CAT1614-05 | 2024-06-10 |
| 28886479300256 | Reach Needle | CAT1614-05 | CAT1614-05 | 2024-06-10 |
| 08886479300108 | Power Cord (OUS) | MS589 | CAT309-01 | 2023-10-19 |
| 08886479300122 | Power Cord (UK) | MS588 | CAT309-03 | 2023-10-19 |
| 08886479300207 | Power Cord (OUS) 15 FT | MS1222 | CAT309-04 | 2023-10-19 |
| 08886479300221 | Power Cord (UK) 15 FT | MS1223 | CAT309-06 | 2023-10-19 |
| 08886479300115 | Power Cord | CAT309-02 | CAT309-02 | 2017-12-19 |
| 08886479300139 | Foot Switch | CAT307 | CAT307 | 2017-12-19 |
| 08886479300214 | Power Cord 15 ft (US) | MS1198 | 309-05 | 2021-07-15 |
| 28886479300157 | Sterile Aquasonic 100 Ultrasound Transmission Gel | MS303 | CAT447-Q06 | 2017-12-19 |
Other Devices Sharing Product Codes#
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| 07613327693553 | Malis | STRYKER CORPORATION | GEI | 2026-02-25 |
| 07613327693560 | Malis | STRYKER CORPORATION | GEI | 2026-02-25 |
| 07613327693577 | Malis | STRYKER CORPORATION | GEI | 2026-02-25 |
| 08886479300306 | RhinAer+ Stylus | Aerin Medical Inc. | GEI | 2025-09-19 |
| 07613327556469 | Neptune | STRYKER CORPORATION | GEI | 2025-01-30 |
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| 07613327548143 | Neptune | STRYKER CORPORATION | GEI | 2024-12-10 |