DEVICE: Secure Catch Tissue Retrieval Pouch Medium with tail attachment (05051223008170)

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Device Identifier (DI) Information

Secure Catch Tissue Retrieval Pouch Medium with tail attachment
PS3406
PS3406
PURPLE SURGICAL INTERNATIONAL LIMITED
05051223008170
GS1
1
The Purple Surgical Secure Catch Tissue Retrieval Pouch has applications in laparoscopic procedures for the safe, convenient removal of tissue specimens such as the appendix, gallbladder, ovaries, fibroids, myomas, omentum, spleen and bowel.
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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
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
KGY Bag, Intestine
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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
Length: 175 Millimeter
Width: 125 Millimeter
Total Volume: 350 Milliliter
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Device Status

In Commercial Distribution
September 17, 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
35051223008171 25 05051223008170 In Commercial Distribution shipping carton
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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

[?]
+441923839333
mail@purplesurgical.com
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