DEVICE: OPTRELL (10846835023015)

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Device Record History
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Device Identifier (DI) Information
OPTRELL
D140901
In Commercial Distribution
D140901
Biosense Webster Inc
10846835023015
GS1

1
020163218 *Terms of Use
Mapping Catheter with TRUEref Technology
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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
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FDA Product Code

[?]
Product Code Product Code Name
DRF CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K211438 000
No CLOSE

Sterilization
Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Keep out of direct sunlight
Special Storage Condition, Specify: Keep Dry
Special Storage Condition, Specify: Do not use if package is damaged
Special Storage Condition, Specify: Do not use if package is opened
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
cc1a1a94-7aab-4d76-b2a0-bb142b07e75b
April 04, 2022
1
March 25, 2022
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)729-9010
RA-BWIUS-Complaints@its.jnj.com
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