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
00840178704702ITDTouchpoint Medical, Inc.BZN2026-05-14
00840178704658ITDTouchpoint Medical, Inc.BZN2026-05-07
06972077026419ALLICAREXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-05-07
06972077026426ALLICAREXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-05-07
G035X1BT70M0MULTIX SOLUTIONS SRLMULTIX SOLUTIONS SRLBZN2026-04-28
00840178704627ITDTouchpoint Medical, Inc.BZN2026-04-13
06972077025955ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077025962ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077025979ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077025986ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077025993ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026006ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026013ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026020ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026037ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026044ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026051ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026068ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026075ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026082ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026099ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026105ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026112ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026129ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026136ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026143ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026150ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026167ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
04056634076856symbio-cart ITD GmbHBZN2026-03-23
04056634081898symbio-cart ITD GmbHBZN2026-03-23