Catalog Number

660005000

Brand Name

HSG Procedure Tray

Version/Model Number

660005000

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

-

Product Code

LKF

Product Code Name

Cannula, Manipulator/Injector, Uterine

Public Device Record Key

969cb490-f711-45b2-9ae2-776c0ddbd888

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 16, 2017

Package DI Number

20886333005745

Quantity per Package

5

Contains DI Package

00886333005741

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box