Catalog Number

-

Brand Name

High Pressure Luer Lock Set, Single Lumen 300mmHg

Version/Model Number

HLL003

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2018

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

HIG

Product Code Name

Insufflator, Hysteroscopic

Public Device Record Key

1ff34655-34a0-4e50-b4cc-06148d5006c3

Public Version Date

July 08, 2022

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

20860936000345

Quantity per Package

10

Contains DI Package

00860936000341

Package Discontinue Date

December 31, 2018

Package Status

Not in Commercial Distribution

Package Type

Box