DEVICE: ENTRIPORT (20653405005213)
Device Identifier (DI) Information
ENTRIPORT
G3-M05S-NB
In Commercial Distribution
G3-M05S-NB
Conmed Corporation
G3-M05S-NB
In Commercial Distribution
G3-M05S-NB
Conmed Corporation
Bladeless Mini Trocar
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
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 |
---|---|
GCJ | Laparoscope, general & plastic surgery |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K142464 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 10 and 32 Degrees Celsius |
Storage Environment Temperature: between 50 and 90 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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Width: 5 Millimeter |
Length: 70 Millimeter |
Device Record Status
f011b3cc-59f5-4b58-ad2e-529e0302a1be
January 09, 2020
4
September 24, 2016
January 09, 2020
4
September 24, 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 |
---|---|---|---|---|---|
10653405005216 | 10 | 20653405005213 | In Commercial Distribution | BOX |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00653405081893
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)237-0169
CUSTOMER_SERVICE@CONMED.COM
CUSTOMER_SERVICE@CONMED.COM