Catalog Number

-

Brand Name

Trinias

Version/Model Number

563-79863-48

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K203535

Product Code

OWB

Product Code Name

Interventional Fluoroscopic X-Ray System

Public Device Record Key

75f5c5c7-98fe-4bf6-b2e6-81dbe9ba4309

Public Version Date

September 27, 2021

Public Version Number

1

DI Record Publish Date

September 17, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-