Catalog Number

9001C0214

Brand Name

Site-Rite

Version/Model Number

9001C0214

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Public Device Record Key

ab2298ef-d3f3-4a0f-a651-95b250c61f56

Public Version Date

June 17, 2022

Public Version Number

6

DI Record Publish Date

September 14, 2016

Package DI Number

20801741037829

Quantity per Package

12

Contains DI Package

10801741037822

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX