ACS-040SMS-10

GUDID 03664539003726

"SET OF 10 ANCHOR BOLTS, LENGTH 40MM, LENGTH OF THE SELF-TAPPING THREAD 5MM ACCESSORY OF MICRODEEP DEPTH ELECTRODE"

DIXI MEDICAL

Depth electrode
Primary Device ID03664539003726
NIH Device Record Key4238c774-9387-4519-8536-6ade0106c0d0
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberANCHOR BOLT
Catalog NumberACS-040SMS-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 Datetrue
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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS103664539003672 [Primary]
GS103664539003726 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-18
Device Publish Date2022-10-10

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

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