Catalog Number

TMI1153

Brand Name

NA

Version/Model Number

Uterine Injector, 2.0

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

K020292,K020292

Product Code

LKF

Product Code Name

Cannula, Manipulator/Injector, Uterine

Public Device Record Key

1855f0c9-c470-483b-a0aa-4f066823ac54

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 07, 2016

Package DI Number

10852073002538

Quantity per Package

12

Contains DI Package

00852073002531

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box