Catalog Number

-

Brand Name

Sensus

Version/Model Number

SRT-100

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K123985

Product Code

JAD

Product Code Name

System, Therapeutic, X-Ray

Public Device Record Key

ebc0a2a0-cea4-4c61-814a-90ff8dc1a112

Public Version Date

January 14, 2019

Public Version Number

1

DI Record Publish Date

December 12, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-