Catalog Number

TMI1161

Brand Name

HSG Kits

Version/Model Number

HSG tray with 7F HS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Safe

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

K032835

Product Code

LKF

Product Code Name

Cannula, Manipulator/Injector, Uterine

Public Device Record Key

b5fd3eb2-82de-4f14-88be-f1c7ddc686a9

Public Version Date

June 27, 2022

Public Version Number

1

DI Record Publish Date

June 17, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-