| Primary Device ID | 07290014036529 |
| NIH Device Record Key | 6dee4239-2a83-42f8-9967-da1a8d78ddcd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MUSE Console |
| Version Model Number | 01 |
| Catalog Number | FMDB9000001 |
| Company DUNS | 532281169 |
| Company Name | MEDIGUS LTD |
| Device Count | 1 |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 |
| Phone | +972543516320 |
| Ronen.Cohen@medigus.com |
| Depth | 37 Centimeter |
| Width | 44 Centimeter |
| Height | 19 Centimeter |
| Storage Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290014036529 [Primary] |
| ODE | Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-05-23 |
| Device Publish Date | 2016-09-20 |
| 07290014036079 - MUSE Staple Cartridge | 2019-05-07 Each box contains 30 sterile single use cartridges Each cartridge contains five standard 4.8 mm titanium staples |
| 07290014036529 - MUSE Console | 2018-05-23The Medigus Ultrasonic Surgical Endostapler (MUSE) System enables the operator to staple the fundus of the stomach to the esophagus, in 2 or more loca |
| 07290014036529 - MUSE Console | 2018-05-23 The Medigus Ultrasonic Surgical Endostapler (MUSE) System enables the operator to staple the fundus of the stomach to the esopha |
| 07290014036062 - MUSE Endostapler | 2018-03-29 The MUSE System consists of a single patient use flexible endostapler (or stapler), a reusable control console, and associated a |