DEVICE: Argyle (10884521029293)
Device Identifier (DI) Information
Argyle
8888561050
In Commercial Distribution
8888561050
Cardinal Health, Inc.
8888561050
In Commercial Distribution
8888561050
Cardinal Health, Inc.
Trocar Catheter,Sharp Tip
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| Yes | |
| No | |
| No | |
| Yes | |
| 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? |
|---|---|---|---|---|
| 62858 | Pleuroscopic/mediastinoscopic trocar blade |
A rigid surgical instrument with a sharp or blunt tip intended to be used in conjunction with a thoracic access cannula (not included) to puncture the thoracic wall (between adjacent ribs) to facilitate placement of the cannula in the pleural and/or mediastinal cavity during a minimally-invasive procedure; it is not intended for pericardial access. It is intended to fill the lumen of a thoracic cannula and is removed once the cannula is in place. This is a reusable device.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| DRC | Trocar |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Special Storage Condition, Specify: Keep dry;AVOID DIRECT SUNLIGHT |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Catheter Gauge: 24 French |
| Length: 15.75 Inch |
Device Record Status
4ce985a0-9b12-4ec5-9ffb-f6cd44d5ee8d
February 19, 2025
10
October 06, 2016
February 19, 2025
10
October 06, 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 |
|---|---|---|---|---|---|
| 00884521029296 | 10 | 10884521029293 | 2016-10-07 | Not in Commercial Distribution | CASE |
| 10884521214378 | 10 | 10884521029293 | 2025-12-31 | In Commercial Distribution | CASE |
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| 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
[?]
No Customer Contact currently defined