IMACTIS®

GUDID B681A100101

Sterile needle holder of the IMACTIS® CT-NAVIGATION system

IMACTIS

Electromagnetic surgical navigation device tracking system
Primary Device IDB681A100101
NIH Device Record Keybea775e2-5446-4478-a861-31b77ebec38f
Commercial Distribution StatusIn Commercial Distribution
Brand NameIMACTIS®
Version Model NumberA10010
Company DUNS260527568
Company NameIMACTIS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB681A100101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAKSystem, X-Ray, Tomography, Computed

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-01-07
Device Publish Date2018-12-07

On-Brand Devices [IMACTIS® ]

B681J020000Navigation station of the IMACTIS® CT-NAVIGATION system
B681J001971Transport suitcase for the navigation station of the IMACTIS® CT-NAVIGATION system
B681J00099US0Power cable of the IMACTIS® CT-NAVIGATION system
B681J000970Cart for the IMACTIS® CT-NAVIGATION system
B681I101002Single use Navigation Kit of the IMACTIS® CT-NAVIGATION system
B681A102001Non-sterile needle holder of the IMACTIS® CT-NAVIGATION system
B681A100101Sterile needle holder of the IMACTIS® CT-NAVIGATION system

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