Catalog Number

-

Brand Name

Echosampler

Version/Model Number

#5164 Echosampler

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"

-

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

K903002,K903002,K903002

Product Code

HFF

Product Code Name

Aspirator, Endometrial

Public Device Record Key

22a1ed66-74c7-4db1-9b92-7261e0bcc144

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

January 17, 2017

Package DI Number

25425017500036

Quantity per Package

125

Contains DI Package

05425017500032

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-