DEVICE: MUSE Staple Cartridge (07290014036079)

Device Identifier (DI) Information

MUSE Staple Cartridge
02
In Commercial Distribution
MMAA9001011
MEDIGUS LTD
07290014036079
GS1

30
532281169 *Terms of Use
Each box contains 30 sterile single use cartridges Each cartridge contains five standard 4.8 mm titanium staples
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Device Characteristics

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

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
Surgical staple, non-bioabsorbable A length of wire, typically U-shaped, designed to mechanically fasten internal tissues together (e.g., the subcuticular closure of skin or the approximation of the ends of bowel) to facilitate healing typically in abdominal, thoracic, gynaecologic, orthopaedic, or plastic and reconstructive surgery. The device is made of a material that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal). 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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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between -20 and 65 Degrees Celsius
Storage Environment Humidity: between 0 and 75 Percent (%) Relative Humidity
Handling Environment Temperature: between -20 and 65 Degrees Celsius
Handling Environment Humidity: between 0 and 75 Percent (%) Relative Humidity
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

69d03cff-a294-4b00-bf36-e314f7f6ac86
March 29, 2018
2
September 24, 2015
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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: 07290014036086 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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