Empower RF Catheter 10010

GUDID 00856571007241

The EMPOWER RF Catheter is a monopolar endoscopic tool that is used to deliver controlled radiofrequency (RF) energy to a target site within the upper airway or tracheobronchial tree when connected to a standard electrosurgical generator. The EMPOWER RF Catheter is inserted through the bronchoscope/extended working channel of 2.0 mm ID or greater to reach the target site.

BRONCUS MEDICAL INC.

Endoscopic electrosurgical electrode, monopolar, single-use
Primary Device ID00856571007241
NIH Device Record Key16a1eb48-956f-4a3c-86fe-d0d86e35cc0b
Commercial Distribution StatusIn Commercial Distribution
Brand NameEmpower RF Catheter
Version Model Number10010
Catalog Number10010
Company DUNS078684808
Company NameBRONCUS MEDICAL INC.
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone650-428-1600
Emailcustomersupport@broncus.com

Device Dimensions

Outer Diameter1.8 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100856571007241 [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 Date2019-11-11
Device Publish Date2019-11-01

Devices Manufactured by BRONCUS MEDICAL INC.

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