DEVICE: Ultimate Dilating tip trocar with smooth cannula (05051223015208)
Device Identifier (DI) Information
Ultimate Dilating tip trocar with smooth cannula
PS4462ULT
In Commercial Distribution
PS4462ULT
PURPLE SURGICAL INTERNATIONAL LIMITED
PS4462ULT
In Commercial Distribution
PS4462ULT
PURPLE SURGICAL INTERNATIONAL LIMITED
The Ultimate Dilating Tip Trocar has applications in minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used for primary and secondary insertions.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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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
ac98ac99-b11e-46a9-9fea-b0b1e1dc915f
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 |
---|---|---|---|---|---|
55051223015203 | 20 | 35051223015209 | In Commercial Distribution | shipping carton | |
35051223015209 | 5 | 05051223015208 | In Commercial Distribution | inner box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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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