DEVICE: OPTRELL Mapping Catheter with TRUEref Technology (10846835025811)
Device Identifier (DI) Information
OPTRELL Mapping Catheter with TRUEref Technology
D142902
In Commercial Distribution
D142902
Biosense Webster Inc
D142902
In Commercial Distribution
D142902
Biosense Webster Inc
OPTRELL-36 F-J Curve
Device Characteristics
MR Unsafe | |
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? |
---|---|---|---|---|
46355 | Cardiac mapping catheter, percutaneous, single-use |
A sterile, steerable, flexible tube containing multiple electrodes that is introduced percutaneously into the heart chambers in order to transmit electrical impulses for electrophysiological diagnostic examinations, e.g., intracardiac sensing, endocardial recording, stimulation, temporary pacing for evaluation of cardiac arrhythmias, cardioversion (CV) of electrical arrhythmias or electrophysiology (EP) mapping of cardiac structures. It is typically made of plastic with embedded electrodes often of platinum (Pt), iridium, or a composite. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MTD | Catheter, intracardiac mapping, high-density array |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K230253 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Keep dry |
Storage Environment Temperature: between 41 and 77 Degrees Fahrenheit |
Special Storage Condition, Specify: Do not use if use if box is opened |
Storage Environment Temperature: between 5 and 25 Degrees Celsius |
Special Storage Condition, Specify: Do not use if package is damaged |
Special Storage Condition, Specify: Keep away from sunlight |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
49566cc4-8569-41ed-a507-5234be73d9b8
October 12, 2023
1
October 04, 2023
October 12, 2023
1
October 04, 2023
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(800)729-9010
RA-BWIUS-Complaints@its.jnj.com
RA-BWIUS-Complaints@its.jnj.com