FDA UDI
In Commercial Distribution
🇺🇸 United States
MUSE Console
DI: 07290014036529
·
Model: 01
·
MEDIGUS LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MUSE Console
- Primary DI
- 07290014036529
- Version / Model
- 01
- Catalog Number
- FMDB9000001
- Company Name
- MEDIGUS LTD
- Labeler DUNS
- 532281169
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 3
- Public Version Date
- 2018-05-23
- Public Version Status
- Update
- Public Device Record Key
- 6dee4239-2a83-42f8-9967-da1a8d78ddcd
Device Description
The Medigus Ultrasonic Surgical Endostapler (MUSE) System enables the operator to staple the fundus of the stomach to the esophagus, in 2 or more locations around the esophageal circumference, thereby creating a permanent surgical fundoplication. The procedure is completed entirely through the mouth, without any incisions. The system consists of three main parts: the endoscopic stapler, the control console and several accessories. The console contains: • A controller for the camera, ultrasonic range finder and various sensors. • A pump for insufflation and irrigation. • Power and controls for the LED
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ODE | Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd) | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40761 | General-purpose ultrasound imaging system | A stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290014036529 | GS1 |
Customer Contacts
- Phone
- +972543516320
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Depth | 37 | Centimeter | |
| Width | 44 | Centimeter | |
| Height | 19 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -18 – 55 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 85 Percent (%) Relative Humidity