FDA.reportPublic FDA data

Retropsoas Electrode

Primary DI
00810135960557
Brand
Retropsoas Electrode
Company
NVISION BIOMEDICAL TECHNOLOGIES, INC.
Model
ELEC2240
Device description
Retropsoas Electrode, NERVE CUFF TRIAL SIZER, 4/6MM. The EARP Nerve Cuff Electrode is used to perform localized stimulation of neural tissue and to locate, identify, and monitor spinal nerve roots during surgery.
Published
2023-10-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ETNStimulator, Nerve
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETNStimulator, NerveEar, Nose, Throat2
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230853000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230853000EARP Nerve Cuff ElectrodeNvision Biomedical Technologies, Inc.2023-10-06ETN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810135960557PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810135960557008101359605578101359605570810135960557

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
210-598-5641diana@nvisionbiomed.com

Regulatory Flags#

DUNS number
047486041
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810005668088TrigonWD-1001C-7002026-04-24
00810005668095TrigonMTP-22-08-002026-04-24
00810005668101TrigonMTP-22-10-002026-04-24
00810005668118TrigonMTP-22-12-002026-04-24
00810005668125TrigonWD-1000T-MWIS2026-04-24
00810005668187TrigonMTP-18-08-002026-04-24
00810135963565TrigonMTP-18-10-002026-04-24
00810135963572TrigonMTP-18-12-002026-04-24
00810005668132TrigonMTP-22-08T-002026-04-23
00810005668149TrigonMTP-22-10T-002026-04-23
00810005668156TrigonMTP-22-12T-002026-04-23
00810135963589TrigonMTP-18-08T-002026-04-23
00810135963596TrigonMTP-18-10T-002026-04-23
00810135963602TrigonMTP-18-12T-002026-04-23
00810135960502Retropsoas ElectrodeELEC1000-042023-10-25
00810135960519Retropsoas ElectrodeELEC1000-062023-10-25
00810135960526Retropsoas ElectrodeELEC1000-082023-10-25
00810135960533Retropsoas ElectrodeELEC1000-102023-10-25
00810135960540Retropsoas ElectrodeELEC21002023-10-25
00810135960564Retropsoas ElectrodeELEC22802023-10-25

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