Catalog Number

SSIP93068

Brand Name

SE12-3 Gen III®

Version/Model Number

SSIP93068

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

K142100

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Public Device Record Key

92ed92a3-dc77-4c64-97ec-daaeee8e21b5

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

December 08, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-