DEVICE: Mapcath stylet (10815149025275)
Device Identifier (DI) Information
Mapcath stylet
60-2018
Not in Commercial Distribution
60-2018
CORPAK MEDSYSTEMS, INC.
60-2018
Not in Commercial Distribution
60-2018
CORPAK MEDSYSTEMS, INC.
stylet for use with Navigator
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? |
|---|---|---|---|---|
| 44119 | Intravascular catheter stylet magnet detector |
An electrically-powered device designed to rapidly detect and confirm the location and orientation of the tip of a compatible, peripherally-inserted central catheter (PICC) or central venous catheter (CVC) stylet containing one or more small, specially-oriented magnets encapsulated at the distal end. It provides rapid feedback to healthcare personnel on the positioning of the catheter/stylet during initial placement.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| LJS | Catheter,intravascular,therapeutic,long-term greater than 30 days |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Catheter Gauge: 1.1 French |
| Device Size Text, specify: 1.1FR(0.36mm) X 106cm |
| Length: 106 Centimeter |
Device Record Status
3a27ee05-81c2-4d79-9534-4ff3be9dbc18
July 31, 2023
3
August 04, 2016
July 31, 2023
3
August 04, 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 |
|---|---|---|---|---|---|
| 20815149025272 | 10 | 10815149025275 | 2021-01-22 | Not in Commercial Distribution |
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
[?]
+1(847)403-3400
questions@corpak.com
questions@corpak.com