DEVICE: ETHICON (10705031131958)

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Device Identifier (DI) Information

ETHICON
MS1995
MS1995
ETHICON INC.
10705031131958
GS1
1
Surgiflo Endoscopic Appicator
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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
Endoscopic haemostatic agent cannula A sterile device intended to be used during an endoscopic procedure to provide access for the instillation of haemostatic agents to a bleeding surgical site. It consists of a long, single-lumen tube with an atraumatic tip, and is inserted into the body percutaneously, via a port, or a rigid endoscope (e.g., laparoscope). It is made of metal and/or plastic materials, and some types include an inner flexible cannula for use upon removal of the outer rigid cannula; an obturator for expressing the excess agent remaining in the cannula 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
GCJ Laparoscope, general & plastic surgery
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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 15 and 30 Degrees Celsius
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 23, 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
20705031131955 6 10705031131958 In Commercial Distribution CASE
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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
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(877)384-4266
xxx@xxx.xxx
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