DEVICE: MUSE Endostapler (07290014036062)

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Device Identifier (DI) Information

MUSE Endostapler
01
MMAA1006002
MEDIGUS LTD
07290014036062
GS1
1
The MUSE System consists of a single patient use flexible endostapler (or stapler), a reusable control console, and associated accessories including a monitor and staple cartridges. The endoscopic stapler is a single use, sterile device (EtO) which resembles an endoscope in appearance and material construction. The distal tip of the device contains a video camera, ultrasonic range finding sight, illumination, irrigation port, insufflation port, and the staple anvil. The distal tip is retroflexed to align with the staple cartridge located in the shaft of the stapler. An alignment pin in the distal tip is used for initial positioning of the anvil against the cartridge.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Endoscopic manual linear stapler A sterile, hand-held, manual surgical instrument intended to be used during abdominal, gynaecological, paediatric, and thoracic endoscopic (i.e., endotherapy) surgery for the application of surgical staples to approximate internal soft tissues (e.g., two ends of bowel) or for fixation of a surgical mesh to tissue during a laparoscopic procedure; it has no cutting function and may be used during open surgery. The device operates by a manual mechanism (e.g., trigger mechanism) whereby it applies single or multiple linear rows of surgical staples to a portion of tissue. The staples may be housed in a single-use loading unit (SULU) which may be included. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
ODE Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
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Sterilization

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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Storage and Handling

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Storage and Handling
Handling Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Humidity: between 0 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -18 and 55 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Outer Diameter: 15.5 Millimeter
Weight: 2 Kilogram
Length: 295 Centimeter
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Device Status

In Commercial Distribution
September 20, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
Yes
Yes
No
No CLOSE

Customer Contact

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+972543516320
Ronen.Cohen@medigus.com
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