DEVICE: ElectrodeCRF (00811746032626)

Device Identifier (DI) Information

ElectrodeCRF
CRF-U2535P
In Commercial Distribution
CRF-U2535P
CAMBRIDGE INTERVENTIONAL LLC
00811746032626
GS1

1
080897872 *Terms of Use
CRF Radiofrequency Electrode
CLOSE

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?
64233 Percutaneous radio-frequency ablation probe, tumour-ablation, bipolar
A semi-flexible, hand-held surgical instrument intended to be percutaneously introduced via a dedicated cannula [under computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound (US) guidance] to deliver radio-frequency current in a bipolar configuration from a system generator to coagulate/ablate tissues (excluding the CNS and heart) for the treatment of tumours (e.g., in the liver); in addition to percutaneous access it might also be intended for laparoscopic and/or open surgical use. It includes distal electrodes in a bipolar arrangement and may include temperature-sensing elements; the introduction cannula may be included. This is a single-use device.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
GEI Electrosurgical, Cutting & Coagulation & Accessories
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K192715 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

f08d49bc-a750-48b4-934f-f9feffbc491d
September 28, 2023
2
October 16, 2020
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10811746032623 5 00811746032626 In Commercial Distribution
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
781-221-5300
info@cambint.com
CLOSE