DEVICE: Orbiter™ ST (08714729877806)
Device Identifier (DI) Information
Orbiter™ ST
M0043200050
In Commercial Distribution
BOSTON SCIENTIFIC CORPORATION
M0043200050
In Commercial Distribution
BOSTON SCIENTIFIC CORPORATION
Bidirectional Steerable Diagnostic Catheter
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? |
---|---|---|---|---|
16995 | Intracardiac electrode |
An electrical conductor designed for measuring the electrical activity of and/or to provide pacing signals to the interior of the heart; some electrodes are used to provide electric (e.g., radio-frequency) energy to ablate cardiac tissue. It is usually a very small electrode capable of detecting weak bioelectrical signals and/or to provide high electrical energy; it is typically located at or near the tip of cardiac [e.g., electrophysiology (EP), pacing, ablation] catheters. This is a single-use device.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DRF | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING |
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 |
---|
Device Size Text, specify: 7 F Diameter |
Device Size Text, specify: 2.33 mm Diameter |
Device Record Status
d50a7bb3-a4e6-4f2a-8274-9cf5c68c1bbf
March 29, 2018
2
September 24, 2016
March 29, 2018
2
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
[?]
No Customer Contact currently defined