FDA.reportPublic FDA data

Nimbus Electrosurgical Radiofrequency Multitined Expandable Electrode

Primary DI
B452NIM10010BB0
Brand
Nimbus Electrosurgical Radiofrequency Multitined Expandable Electrode
Company
BIOMERICS, LLC
Model
NIM10010BB
Published
2018-03-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXIProbe, Radiofrequency Lesion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXIProbe, Radiofrequency LesionNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121773000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121773000NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODEBiomerics2012-09-21GXI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B452NIM10010BB0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency ablation system probe cannula, single-useA sterile rigid tube designed to provide body tissue access through its lumen for a radio-frequency (RF) probe during RF ablation procedures (typically of peripheral nerves to treat chronic pain) and for the injection/aspiration of fluids (e.g., local anaesthetic agents). It is made of metal (e.g., stainless steel), covered in insulation except for its distal tip, and includes a plastic hub; it is available in a variety of diameters and distal tip lengths/configurations. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8013552705csr@biomerics.com

Regulatory Flags#

DUNS number
829708036
Device count
1
Lot or batch
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B452NIM05010BB0Nimbus Electrosurgical Radiofrequency Multitined Expandable ElectrodeNIM05010BB2018-03-03
B452NIM05010BB1Nimbus Electrosurgical Radiofrequency Multitined Expandable ElectrodeNIM05010BB2018-03-03
B452NIM10010BB1Nimbus Electrosurgical Radiofrequency Multitined Expandable ElectrodeNIM10010BB2018-03-03
B452NIM10010BBCS0Nimbus Electrosurgical Radiofrequency Multitined Expandable ElectrodeNIM10010BBCS2018-03-03
B452NIM10010BBCS1Nimbus Electrosurgical Radiofrequency Multitined Expandable ElectrodeNIM10010BBCS2018-03-03
B452NIM15010BB0Nimbus Electrosurgical Radiofrequency Multitined Expandable ElectrodeNIM15010BB2018-03-03
B452NIM15010BB1Nimbus Electrosurgical Radiofrequency Multitined Expandable ElectrodeNIM15010BB2018-03-03

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Primary DI, Brand, Company table
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