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Imactis®

FDA UDI

Class I (US FDA UDI)

by Imactis

Identity

Trade Name
IMACTIS® FDA UDI
Generic Name
Utility trolley FDA UDI
Device Name
Cart for the IMACTIS® CT-NAVIGATION system FDA UDI
Model / Reference
J00097 FDA UDI
Description
Cart for the IMACTIS® CT-NAVIGATION system FDA UDI

Identifiers

Catalog Number
MA-J00097 FDA UDI
Primary DI / UDI-DI
B681J000970 FDA UDI
FDA Product Code
BZN FDA UDI
GMDN Term
Utility trolley FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
868.6175 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Utility trolley

Imactis® by Imactis — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Utility trolley.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Imactis

Sources (1)

  • FDA UDI dce00d62-728a-4172-a2a9-2dcea6df2dde 34 fields · synced Jun 8, 2026