Retropsoas Electrode

GUDID 00810135960557

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.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

General internal orthopaedic fixation system implantation kit
Primary Device ID00810135960557
NIH Device Record Keyf92aaf58-4a14-4bb8-ae8f-15109e64c04d
Commercial Distribution StatusIn Commercial Distribution
Brand NameRetropsoas Electrode
Version Model NumberELEC2240
Company DUNS047486041
Company NameNVISION BIOMEDICAL TECHNOLOGIES, 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com
Phone210-598-5641
Emaildiana@nvisionbiomed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810135960557 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MDMInstrument, Manual, Surgical, General Use

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810135960557]

Moist Heat or Steam Sterilization

[00810135960557]

Moist Heat or Steam Sterilization

[00810135960557]

Moist Heat or Steam Sterilization

[00810135960557]

Moist Heat or Steam Sterilization

[00810135960557]

Moist Heat or Steam Sterilization

[00810135960557]

Moist Heat or Steam Sterilization

[00810135960557]

Moist Heat or Steam Sterilization

[00810135960557]

Moist Heat or Steam Sterilization

[00810135960557]

Moist Heat or Steam Sterilization

[00810135960557]

Moist Heat or Steam Sterilization

[00810135960557]

Moist Heat or Steam Sterilization

[00810135960557]

Moist Heat or Steam Sterilization

[00810135960557]

Moist Heat or Steam Sterilization

[00810135960557]

Moist Heat or Steam Sterilization

[00810135960557]

Moist Heat or Steam Sterilization

[00810135960557]

Moist Heat or Steam Sterilization

[00810135960557]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-02
Device Publish Date2023-10-25

On-Brand Devices [Retropsoas Electrode]

00810135960564Retropsoas Electrode, NERVE CUFF TRIAL SIZER, 8/10MM. The EARP Nerve Cuff Electrode is used t
00810135960557Retropsoas Electrode, NERVE CUFF TRIAL SIZER, 4/6MM. The EARP Nerve Cuff Electrode is used to
00810135960540Retropsoas Electrode, NERVE CUFF APPLICATOR. The EARP Nerve Cuff Electrode is used to perform
00810135960533Retropsoas Electrode, NERVE CUFF ELECTRODE, 10MM The EARP Nerve Cuff Electrode is used to per
00810135960526Retropsoas Electrode, NERVE CUFF ELECTRODE, 8MM The EARP Nerve Cuff Electrode is used to perf
00810135960519Retropsoas Electrode, NERVE CUFF ELECTRODE, 6MM The EARP Nerve Cuff Electrode is used to perf
00810135960502Retropsoas Electrode, NERVE CUFF ELECTRODE, 4MM The EARP Nerve Cuff Electrode is used to perf
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