BrainLab NaviVision Sleeve Guide BLNG-2X

GUDID 00841823100733

Ad-Tech Medical Instrument Corporation

Neurological stereotactic surgery system
Primary Device ID00841823100733
NIH Device Record Key3609bb89-a2b2-487f-93bc-686218fe3d9d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBrainLab NaviVision Sleeve Guide
Version Model NumberBLNG-2X
Catalog NumberBLNG-2X
Company DUNS174813410
Company NameAd-Tech Medical Instrument Corporation
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)776-1555
Emailsales@adtechmedical.com
Phone+1(800)776-1555
Emailsales@adtechmedical.com
Phone+1(800)776-1555
Emailsales@adtechmedical.com
Phone+1(800)776-1555
Emailsales@adtechmedical.com
Phone+1(800)776-1555
Emailsales@adtechmedical.com
Phone+1(800)776-1555
Emailsales@adtechmedical.com
Phone+1(800)776-1555
Emailsales@adtechmedical.com
Phone+1(800)776-1555
Emailsales@adtechmedical.com
Phone+1(800)776-1555
Emailsales@adtechmedical.com
Phone+1(800)776-1555
Emailsales@adtechmedical.com
Phone+1(800)776-1555
Emailsales@adtechmedical.com
Phone+1(800)776-1555
Emailsales@adtechmedical.com
Phone+1(800)776-1555
Emailsales@adtechmedical.com
Phone+1(800)776-1555
Emailsales@adtechmedical.com
Phone+1(800)776-1555
Emailsales@adtechmedical.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored and used within typical hospital/office room ambient temperature and humidity conditions

Device Identifiers

Device Issuing AgencyDevice ID
GS100841823100733 [Primary]

FDA Product Code

FZXGuide, surgical, instrument

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00841823100733]

Ethylene Oxide


[00841823100733]

Ethylene Oxide


[00841823100733]

Ethylene Oxide


[00841823100733]

Ethylene Oxide


[00841823100733]

Ethylene Oxide


[00841823100733]

Ethylene Oxide


[00841823100733]

Ethylene Oxide


[00841823100733]

Ethylene Oxide


[00841823100733]

Ethylene Oxide


[00841823100733]

Ethylene Oxide


[00841823100733]

Ethylene Oxide


[00841823100733]

Ethylene Oxide


[00841823100733]

Ethylene Oxide


[00841823100733]

Ethylene Oxide


[00841823100733]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-08
Device Publish Date2023-08-31

Devices Manufactured by Ad-Tech Medical Instrument Corporation

00841823109743 - Spencer Probe Depth Electrode2024-07-18
00841823109750 - Spencer Probe Depth Electrode2024-07-18
00841823109767 - Spencer Probe Depth Electrode2024-07-18
00841823109774 - Spencer Probe Depth Electrode2024-07-18
00841823109781 - Spencer Probe Depth Electrode2024-07-18
00841823109798 - Spencer Probe Depth Electrode2024-07-18
00841823109613 - Macro Depth Electrode2024-04-15
00841823109620 - Macro Depth Electrode2024-04-15

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.