DEVICE: Auto-shield trocar, ribbed cannula (05051223000716)
Device Identifier (DI) Information
Auto-shield trocar, ribbed cannula
PS3512
In Commercial Distribution
PS3512
PURPLE SURGICAL INTERNATIONAL LIMITED
PS3512
In Commercial Distribution
PS3512
PURPLE SURGICAL INTERNATIONAL LIMITED
The AutoShield Trocar is designed to provide a port of entry into the abdominal cavity during laparoscopic & endoscopic procedures.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
Yes | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
42412 | Laparoscopic access cannula, single-use |
A 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 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 additionally be intended for thoracoscopy whereby the valve may not be required. 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. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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HET | Laparoscope, Gynecologic (And Accessories) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: 12mm diameter x 100mm length |
Device Record Status
53830ff6-b147-45e3-9f98-cd36b022b0e5
January 09, 2020
3
September 17, 2016
January 09, 2020
3
September 17, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
35051223000717 | 10 | 05051223000716 | In Commercial Distribution | shelf box | |
55051223000711 | 40 | 35051223000717 | In Commercial Distribution | shippinng carton |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+441923839333
mail@purplesurgical.com
mail@purplesurgical.com