MUSE Console

Primary DI
07290014036529
Brand
MUSE Console
Company
MEDIGUS LTD
Model
01
Catalog number
FMDB9000001
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
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ODEEndoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODEEndoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290014036529PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290014036529072900140365297290014036529

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose ultrasound imaging systemA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth37Centimeter
Height19Centimeter
Width44Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-18 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+972543516320Ronen.Cohen@medigus.com

Regulatory Flags#

DUNS number
532281169
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290014036079MUSE Staple Cartridge 02MMAA90010112015-09-24
07290014036062MUSE Endostapler01MMAA10060022016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450848135SerosaFuse®Merit Medical Systems, Inc.ODE2026-02-03
00884450848111EsophyX® Z+Merit Medical Systems, Inc.ODE2026-01-14
00884450848128SerosaFuse®Merit Medical Systems, Inc.ODE2026-01-14
00810275014011SerosaFuse® Implantable Fastener KitENDOGASTRIC SOLUTIONS, INC.ODE2019-03-14
00810275013052SerosaFuse® 7.5mm Implantable Fastener CartridgesENDOGASTRIC SOLUTIONS, INC.ODE2019-03-13
00810275011089EsophyX Z+ENDOGASTRIC SOLUTIONS, INC.ODE2017-11-16
07290014036062MUSE EndostaplerMEDIGUS LTDODE2016-09-20
00810275011065EsophyX2 HDENDOGASTRIC SOLUTIONS, INC.ODE2015-10-24
00810275011072EsophyX ZENDOGASTRIC SOLUTIONS, INC.ODE2015-10-24
008102750130146.5mm CartridgeENDOGASTRIC SOLUTIONS, INC.ODE2015-10-24
008102750130217.5mm CartridgeENDOGASTRIC SOLUTIONS, INC.ODE2015-10-24
008102750130386.5mm & 7.5mm CartridgeENDOGASTRIC SOLUTIONS, INC.ODE2015-10-24
07290014036079MUSE Staple CartridgeMEDIGUS LTDODE2015-09-24