MUSE Staple Cartridge MMAA9001011

GUDID 07290014036079

Each box contains 30 sterile single use cartridges Each cartridge contains five standard 4.8 mm titanium staples

MEDIGUS LTD

Surgical staple loading unit, non-cutting
Primary Device ID07290014036079
NIH Device Record Key69d03cff-a294-4b00-bf36-e314f7f6ac86
Commercial Distribution StatusIn Commercial Distribution
Brand NameMUSE Staple Cartridge
Version Model Number02
Catalog NumberMMAA9001011
Company DUNS532281169
Company NameMEDIGUS LTD
Device Count30
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS107290014036079 [Primary]
GS107290014036086 [Unit of Use]

FDA Product Code

ODEEndoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-07
Device Publish Date2015-09-24

Devices Manufactured by MEDIGUS LTD

07290014036079 - MUSE Staple Cartridge2019-05-07Each box contains 30 sterile single use cartridges Each cartridge contains five standard 4.8 mm titanium staples
07290014036079 - MUSE Staple Cartridge2019-05-07 Each box contains 30 sterile single use cartridges Each cartridge contains five standard 4.8 mm titanium staples
07290014036529 - MUSE Console2018-05-23 The Medigus Ultrasonic Surgical Endostapler (MUSE) System enables the operator to staple the fundus of the stomach to the esopha
07290014036062 - MUSE Endostapler2018-03-29 The MUSE System consists of a single patient use flexible endostapler (or stapler), a reusable control console, and associated a

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