Catalog Number

TMI1175

Brand Name

NA

Version/Model Number

Endometrial Sampler

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

K990387,K990387

Product Code

HHK

Product Code Name

Curette, Suction, Endometrial (And Accessories)

Public Device Record Key

80a3117c-6bf2-49ce-84fa-375fe54a8d25

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 11, 2016

Package DI Number

10852073002750

Quantity per Package

25

Contains DI Package

00852073002753

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box