DEVICE: Detachable endo pocket (04714127863504)

Device Identifier (DI) Information

Detachable endo pocket
FEP936116
In Commercial Distribution

UNIMAX MEDICAL SYSTEMS INC.
04714127863504
GS1

1
658122465 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
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
Tissue extraction bag An impervious, flexible, sterile container intended to be used during minimally-invasive, typically keyhole, surgical techniques (e.g., laparoscopic) to extract dissected patient body tissue. The device is inserted into the body through a large bore cannula port, and the tissue to be extracted is placed in the bag with trans-cannula instruments and evacuated through the cannula. The device typically includes an x-ray detectable thread. This device may be used for surgical interventions such as an appendectomy, colonectomy, lymphadenectomy, or gallbladder removal. 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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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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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
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Width: 3 Inch
Height: 6 Inch
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Device Record Status

612f4507-4c7a-44a7-a05b-c51066f4dde1
April 03, 2018
3
December 08, 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
24714127863508 50 14714127863501 In Commercial Distribution carton
14714127863501 5 04714127863504 In Commercial Distribution box
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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)

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

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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