| Primary Device ID | 28886479300157 |
| NIH Device Record Key | a8959ef7-30f2-4d3f-8d5e-a3a57d812cf2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sterile Aquasonic 100 Ultrasound Transmission Gel |
| Version Model Number | MS303 |
| Catalog Number | CAT447-Q06 |
| Company DUNS | 051512253 |
| Company Name | AERIN MEDICAL INC. |
| Device Count | 6 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08886479300153 [Unit of Use] |
| GS1 | 28886479300157 [Primary] |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2019-02-18 |
| Device Publish Date | 2017-12-19 |
| 28886479300256 - Reach Needle | 2024-06-18 Single use anesthesia needle |
| 08886479300269 - VivAer® Stylus | 2024-01-15 The VivAer® Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue. The VivAer® |
| 08886479300108 - Power Cord (OUS) | 2023-10-27 The power cord is an accessory for the Aerin Console which is an AC (alternating current) radiofrequency generator that incorpor |
| 08886479300122 - Power Cord (UK) | 2023-10-27 The power cord is an accessory for the Aerin Console which is an AC (alternating current) radiofrequency generator that incorpor |
| 08886479300207 - Power Cord (OUS) 15 FT | 2023-10-27 The power cord is an accessory for the Aerin Console which is an AC (alternating current) radiofrequency generator that incorpor |
| 08886479300221 - Power Cord (UK) 15 FT | 2023-10-27 The power cord is an accessory for the Aerin Console which is an AC (alternating current) radiofrequency generator that incorpor |
| 08886479300023 - InSeca ARC Stylus | 2023-04-04 The InSeca ARC Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue. The InSeca |
| 08886479300030 - Aerin Console | 2023-04-04 The Aerin Console is an AC (alternating current) radiofrequency generator. It incorporates user interface software to control, m |