MUSE Endostapler MMAA1006002

GUDID 07290014036062

The MUSE System consists of a single patient use flexible endostapler (or stapler), a reusable control console, and associated accessories including a

MEDIGUS LTD

Endoscopic manual linear stapler

• Primary Device ID: 07290014036062
• NIH Device Record Key: b61c85f0-731f-472a-9c12-c91dfc5f14dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MUSE Endostapler
• Version Model Number: 01
• Catalog Number: MMAA1006002
• 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +972543516320
• Email: Ronen.Cohen@medigus.com

Device Dimensions

• Outer Diameter: 15.5 Millimeter
• Weight: 2 Kilogram
• Length: 295 Centimeter

Operating and Storage Conditions

• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -18 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290014036062 [Primary]

FDA Product Code

• ODE: Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[07290014036062]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-20

Devices Manufactured by MEDIGUS LTD

• 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: 2018-05-23 The Medigus Ultrasonic Surgical Endostapler (MUSE) System enables the operator to staple the fundus of the stomach to the esopha
• 07290014036062 - MUSE Endostapler: 2018-03-29The MUSE System consists of a single patient use flexible endostapler (or stapler), a reusable control console, and associated accessories including a
• 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