INFINITT RT Mobile - INFINITT Healthcare Co.,Ltd.

Duns Number:688319156

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

INFINITT RT Mobile

Version/Model Number

INFINITT RT Mobile

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

LMD

Product Code Name

System, Digital Image Communications, Radiological

Device Record Status

Public Device Record Key

3d07d54f-7816-4f6e-b2a2-cda573dc008c

Public Version Date

September 02, 2022

Public Version Number

1

DI Record Publish Date

August 25, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INFINITT HEALTHCARE CO.,LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 12