DEVICE: Auto-shield trocar, ribbed cannula plus additional cannula (05051223004028)

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Device Identifier (DI) Information

Auto-shield trocar, ribbed cannula plus additional cannula
PS3513
PS3513
PURPLE SURGICAL INTERNATIONAL LIMITED
05051223004028
GS1
1
The AutoShield Trocar 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
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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: 5mm 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
35051223004029 10 05051223004028 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

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+441923839333
mail@purplesurgical.com
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