Catalog Number

HS2100SS

Brand Name

Hays Inc

Version/Model Number

HS2100SS

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K211969,K211969,K211969

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

06e21eea-1382-402b-b897-b6f142cc0974

Public Version Date

December 24, 2021

Public Version Number

2

DI Record Publish Date

February 04, 2021

Package DI Number

00860003700884

Quantity per Package

20

Contains DI Package

00860003700853

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Case