ACS-789/82R

GUDID 03664539003900

GUIDE FOR Ø 2.45MM ACCESSORIES ACCESSORY OF MICRODEEP DEPTH ELECTRODE

DIXI MEDICAL

Depth electrode
Primary Device ID03664539003900
NIH Device Record Key2628a9ed-8c9d-44cc-a14f-e284e02c8f42
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberINSTRUMENT GUIDE
Catalog NumberACS-789/82R
Company DUNS268009609
Company NameDIXI MEDICAL
Device Count1
DM Exempttrue
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+33381889890
Emailinfo@diximedical.com
Phone+33381889890
Emailinfo@diximedical.com
Phone+33381889890
Emailinfo@diximedical.com
Phone+33381889890
Emailinfo@diximedical.com
Phone+33381889890
Emailinfo@diximedical.com
Phone+33381889890
Emailinfo@diximedical.com
Phone+33381889890
Emailinfo@diximedical.com
Phone+33381889890
Emailinfo@diximedical.com
Phone+33381889890
Emailinfo@diximedical.com
Phone+33381889890
Emailinfo@diximedical.com
Phone+33381889890
Emailinfo@diximedical.com
Phone+33381889890
Emailinfo@diximedical.com
Phone+33381889890
Emailinfo@diximedical.com
Phone+33381889890
Emailinfo@diximedical.com
Phone+33381889890
Emailinfo@diximedical.com
Phone+33381889890
Emailinfo@diximedical.com
Phone+33381889890
Emailinfo@diximedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS103664539003900 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZLElectrode, Depth

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03664539003900]

Moist Heat or Steam Sterilization


[03664539003900]

Moist Heat or Steam Sterilization


[03664539003900]

Moist Heat or Steam Sterilization


[03664539003900]

Moist Heat or Steam Sterilization


[03664539003900]

Moist Heat or Steam Sterilization


[03664539003900]

Moist Heat or Steam Sterilization


[03664539003900]

Moist Heat or Steam Sterilization


[03664539003900]

Moist Heat or Steam Sterilization


[03664539003900]

Moist Heat or Steam Sterilization


[03664539003900]

Moist Heat or Steam Sterilization


[03664539003900]

Moist Heat or Steam Sterilization


[03664539003900]

Moist Heat or Steam Sterilization


[03664539003900]

Moist Heat or Steam Sterilization


[03664539003900]

Moist Heat or Steam Sterilization


[03664539003900]

Moist Heat or Steam Sterilization


[03664539003900]

Moist Heat or Steam Sterilization


[03664539003900]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-11
Device Publish Date2024-04-03

Devices Manufactured by DIXI MEDICAL

03664539004037 - NA2024-10-01 SUBDURAL ELECTRODE WITH CONNECTION CABLE, STRIP, 1x4 CONTACTS
03664539004044 - NA2024-10-01 SUBDURAL ELECTRODE WITH CONNECTION CABLE, STRIP, 1x6 CONTACTS
03664539004051 - NA2024-10-01 SUBDURAL ELECTRODE WITH CONNECTION CABLE, STRIP, 1x8 CONTACTS
03664539004068 - NA2024-10-01 SUBDURAL ELECTRODE WITH CONNECTION CABLE, GRID, 2x4 CONTACTS
03664539004075 - NA2024-10-01 SUBDURAL ELECTRODE WITH CONNECTION CABLE, GRID, 2x6 CONTACTS
03664539004082 - NA2024-10-01 SUBDURAL ELECTRODE WITH CONNECTION CABLE, GRID, 2x8 CONTACTS
03664539004099 - NA2024-10-01 SUBDURAL ELECTRODE WITH CONNECTION CABLE, GRID, 4x4 CONTACTS
03664539003900 - NA2024-04-11GUIDE FOR Ø 2.45MM ACCESSORIES ACCESSORY OF MICRODEEP DEPTH ELECTRODE
03664539003900 - NA2024-04-11 GUIDE FOR Ø 2.45MM ACCESSORIES ACCESSORY OF MICRODEEP DEPTH ELECTRODE

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