Catalog Number

-

Brand Name

HSG Trays/Kits 7fr

Version/Model Number

06-307

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 27, 2021

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

K092969

Product Code

LKF

Product Code Name

Cannula, Manipulator/Injector, Uterine

Public Device Record Key

25f93b75-41f6-4248-a3a0-bcd95b861827

Public Version Date

April 05, 2021

Public Version Number

1

DI Record Publish Date

March 27, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-