FDA.reportPublic FDA data

IMACTIS®

Primary DI
B681J000970
Brand
IMACTIS®
Company
IMACTIS
Model
J00097
Catalog number
MA-J00097
Device description
Cart for the IMACTIS® CT-NAVIGATION system
Published
2018-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B681J000971PackageHIBCC1In Commercial Distribution
B681J000970PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Utility trolleyA cart designed for transporting/supplying general-purpose goods, devices, medical equipment, or supplies within a hospital/institution department or ward. This trolley (cart) may have one or more open platforms and may have a handle(s) for pushing the trolley.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
260527568
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B681A100101IMACTIS®A100102018-12-07
B681A102001IMACTIS®A102002018-12-07
B681I101002IMACTIS®I10100MA-I101002018-12-07
B681J00099US0IMACTIS®J00099_USMA-J00099_US2018-12-07
B681J001971IMACTIS®J001972018-12-07
B681J020000IMACTIS®J02000MA-J020002018-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840178704955ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178704962ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178704979ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178704986ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178704993ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705006ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705013ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705020ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705037ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705044ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705051ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705068ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705075ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705082ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705099ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705105ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705112ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705129ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705136ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705143ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705150ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705167ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705174ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705181ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705198ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705204ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705211ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705235ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178704863ITDTouchpoint Medical, Inc.BZN2026-08-03
00840178704122ITDTouchpoint Medical, Inc.BZN2026-07-07