BIG-TIP™

GUDID 08809295141519

RF Medical Co.,Ltd.

Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar
Primary Device ID08809295141519
NIH Device Record Key9d1b9d0c-affa-4136-b8a0-941bcc998140
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIG-TIP™
Version Model NumberCWT 1525B
Company DUNS690514869
Company NameRF Medical Co.,Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809295141519 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-15
Device Publish Date2025-09-05

On-Brand Devices [BIG-TIP™]

08809559961013BT 1005OB
08809295149591CWT 3520B
08809295149584CWT 3515B
08809295149577CWT 3510B
08809295149560CWT 2515B
08809295149553CWT 2510B
08809295149546CWT 2015B
08809295149539CWT 2010B
08809295149522CWT 3520RB
08809295149515CWT 3515RB
08809295149508CWT 3510RB
08809295149492CWT 2515RB
08809295149485CWT 2510RB
08809295149478CWT 2015RB
08809295149461CWT 2010RB
08809295149454BTW 2040B
08809295149447BTW 2035B
08809295149430BTW 1540B
08809295149423BTW 1535B
08809295149089BT+ 2540B
08809295149072BT+ 2535B
08809295149065BT+ 2530B
08809295149058BT+ 2525B
08809295149041BT+ 2520B
08809295149034BT+ 2515B
08809295149027BT+ 2510B
08809295149010BT+ 2040B
08809295149003BT+ 2035B
08809295148990BT+ 2025B
08809295148983BT+ 2020B
08809295148976BT+ 1540B
08809295148969BT+ 1535B
08809295148952BT+ 1525B
08809295148945BT+ 1520B
08809295148938BT+ 1515B
08809295148921BT+ 1510B
08809295148914BT 2535B
08809295148907BT 2525B
08809295148891BT 2520B
08809295148884BT 2515B
08809295148877BT 2510B
08809295148860BT 2035B
08809295148853BT 1535B
08809295141830CWT 3530RB
08809295141823CWT 3525RB
08809295141816CWT 2530RB
08809295141809CWT 2525RB
08809295141793CWT 2520RB
08809295141786CWT 2030RB
08809295141779CWT 2025RB

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