NICO BrainPath

GUDID 00816744027452

Kit - 1X 11 mm & 13.5 mm

NICO CORPORATION

Neurosurgical procedure kit, non-medicated, reusable
Primary Device ID00816744027452
NIH Device Record Key641950bd-18d0-4950-a5c4-ea0c676aaea5
Commercial Distribution StatusIn Commercial Distribution
Brand NameNICO BrainPath
Version Model NumberNN-7045
Company DUNS829838288
Company NameNICO CORPORATION
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone317-660-7118
Emailinfo@NICOneuro.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100816744027452 [Primary]

FDA Product Code

GZTRetractor, Self-Retaining, For Neurosurgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816744027452]

Hydrogen Peroxide;Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-13
Device Publish Date2019-06-05

On-Brand Devices [NICO BrainPath]

0081674402907495 mm Stylet
00816744029050Manipulation Tool
10816744028333Sheath 11 mm x 75 mm
10816744028326Sheath 11 mm x 60 mm
10816744028319Sheath 11 mm x 50 mm
00816744028305Sheath 13.5 mm x 95 mm
10816744028265Shepherd's Hook Budde
10816744028258Shepherd's Hook Sugita
10816744028241Shepherd's Hook Greenberg
10816744028135Sheath 13.5 mm x 75 mm
10816744028128Sheath 13.5 mm x 60 mm
10816744028111Sheath 13.5 mm x 50 mm
00816744027445Kit - 2X 11 mm & 13.5 mm
00816744027438Kit - 13.5 mm x 95 mm Upgrade
00816744027421Kit - 2X 13.5 mm
00816744027414Kit 13.5 mm
00816744027407Kit - 2X 11 mm
00816744027391Kit 11 mm
00816744027384Obturator 11 mm x 75 mm
00816744027377Obturator 11 mm x 60 mm
00816744027360Obturator 11 mm x 50 mm
00816744027353Obturator 13.5 mm x 95 mm
00816744027261Obturator 13.5 mm x 50 mm (STGold)
00816744027193Sterilization Tray
00816744027179Obturator 13.5 mm x 75 mm
00816744027162Obturator 13.5 mm x 60 mm
00816744027155Obturator 13.5 mm x 50 mm
00816744027452Kit - 1X 11 mm & 13.5 mm
00816744028428Select Lock Shepherd's Hook - Greenberg
10816744038455Navigation Probe Adapter

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