ThermiRF+ ThermiRF+

GUDID 00817771029044

Radiofrequency Temp Controlled Generator

Celling Biosciences

Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator
Primary Device ID00817771029044
NIH Device Record Key034b584c-35d8-4461-8ee7-59d89ef71506
Commercial Distribution StatusIn Commercial Distribution
Brand NameThermiRF+
Version Model NumberThermiRF+
Catalog NumberThermiRF+
Company DUNS021560394
Company NameCelling Biosciences
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817771029044 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-25
Device Publish Date2023-09-17

Devices Manufactured by Celling Biosciences

00817771028962 - Thermi Disposable RF Electrode (Qty1)2023-09-25 Thermi Disposable RF Electrode - 50W Qty 1
00817771028979 - Thermi Disposable RF Electrode (Qty 5)2023-09-25 Thermi Disposable RF Electrode - 50W Qty 5
00817771028986 - Thermi Disposable RF Electrode (Qty 1)2023-09-25 Thermi Disposable RF Electrode - Qty 1
00817771028993 - Thermi Disposable RF Electrode (Qty 5)2023-09-25 Thermi Disposable RF Electrode - Qty 5
00817771029006 - Reusable connector cable for disposable electrodes2023-09-25 Reusable connector cable for disposable electrodes
00817771029013 - RF Disposable Grounding Pad2023-09-25 RF Disposable Grounding Pad Qty 20
00817771029020 - Thermi Disposable RF Electrode (Qty 1)2023-09-25 Thermi Disposable RF Electrode - Qty 1
00817771029037 - Thermi Disposable RF Electrode (Qty 5)2023-09-25 Thermi Disposable RF Electrode - Qty 5

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.