Catalog Number

3760193601411

Brand Name

C6-1X®

Version/Model Number

SSIP95101

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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)

Yes

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

c13703f0-aa33-495a-96db-9ef3e91a5de6

Public Version Date

January 07, 2019

Public Version Number

1

DI Record Publish Date

December 07, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-