DEVICE: Universal cannula (05051223004004)

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Device Identifier (DI) Information

Universal cannula
PS3508
PS3508
PURPLE SURGICAL INTERNATIONAL LIMITED
05051223004004
GS1
1
The Universal Cannula is designed to provide a port of entry into the abdominal cavity during laparoscopic & endoscopic procedures.
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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
Laparoscopic access cannula, single-use A sterile, single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is often provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall; if the trocar is included it may be referred to as a trocar or trocar assembly. It is available in a variety of dimensions and/or designs. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
HET Laparoscope, Gynecologic (And Accessories)
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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
Device Size Text, specify: 10mm diameter x 100mm length
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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
50551223004009 40 35051223004005 In Commercial Distribution shipping carton
35051223004005 10 05051223004004 In Commercial Distribution shelf 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)

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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

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+441923839333
mail@purplesurgical.com
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