ACS-015SMS-10

GUDID 03664539000640

SET OF 10 ANCHOR BOLTS, LENGTH 15MM, ACCESSORY OF MICRODEEP DEPTH ELECTRODE

DIXI MEDICAL

Depth electrode
Primary Device ID03664539000640
NIH Device Record Key9066196c-94df-4ea1-95f0-de7ffede069a
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberANCHOR BOLT
Catalog NumberACS-015SMS-10
Company DUNS268009609
Company NameDIXI MEDICAL
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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 Dimensions

Length15 Millimeter
Length15 Millimeter
Length15 Millimeter
Length15 Millimeter
Length15 Millimeter
Length15 Millimeter
Length15 Millimeter
Length15 Millimeter
Length15 Millimeter
Length15 Millimeter
Length15 Millimeter
Length15 Millimeter
Length15 Millimeter
Length15 Millimeter
Length15 Millimeter
Length15 Millimeter
Length15 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS103664539000640 [Primary]
GS103664539003269 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZLElectrode, Depth

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-09-23
Device Publish Date2017-12-14

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 - NA2024-04-11 GUIDE FOR Ø 2.45MM ACCESSORIES ACCESSORY OF MICRODEEP DEPTH ELECTRODE

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