FUSE - FUSE version 1.09 - PATTERSON TECHNOLOGY CENTER

Duns Number:062232311

Device Description: FUSE version 1.09

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More Product Details

Catalog Number

-

Brand Name

FUSE

Version/Model Number

1.09

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 23, 2021

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

LLZ

Product Code Name

System, Image Processing, Radiological

Device Record Status

Public Device Record Key

5309b01f-3ddd-42b1-ab9d-49854908e7c5

Public Version Date

March 25, 2021

Public Version Number

2

DI Record Publish Date

September 19, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PATTERSON TECHNOLOGY CENTER" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 42