DEVICE: Barrx (10884521189379)
Device Identifier (DI) Information
Barrx
90-9200
In Commercial Distribution
Covidien LP
90-9200
In Commercial Distribution
Covidien LP
Ultra Long RFA Focal Catheter,80 Applications
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? |
---|---|---|---|---|
66665 | Gastrointestinal radio-frequency ablation system catheter |
A semi-flexible tubular device with a bipolar electrode(s) at its distal end intended to be endoscopically introduced into the gastrointestinal (GI) tract (e.g., oesophagus, stomach, rectum, anus) to deliver radio-frequency (RF) current from a connected RF generator (not included) for focal ablation of a GI lesion (e.g., neoplasm); it may be intended for coagulation however it is not intended for electrosurgical cutting. It typically includes a closed fluid circuit for cooling of the tip. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GEI | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K120431 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Width: 13 Millimeter |
Length: 40 Millimeter |
Device Record Status
3c0e8625-693f-4c0e-9c17-ff0e2cdf8ec0
February 14, 2023
7
September 24, 2016
February 14, 2023
7
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 |
---|---|---|---|---|---|
No Package DIs found |
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(508)261-8000
covidien.udi@covidien.com
covidien.udi@covidien.com