Catalog Number

9001C0212

Brand Name

Site-Rite

Version/Model Number

9001C0212

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

c7578184-b3c5-40a6-bb51-7a3b3a8de422

Public Version Date

June 17, 2022

Public Version Number

6

DI Record Publish Date

September 14, 2016

Package DI Number

10801741037815

Quantity per Package

10

Contains DI Package

00801741037818

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA