Catalog Number

-

Brand Name

Tubing Set - Single Lumen, Inflow with Dual Outflow

Version/Model Number

LL0004

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K091939,K133799,K133799,K091939

Product Code

HIG

Product Code Name

Insufflator, Hysteroscopic

Public Device Record Key

97f26954-43a1-4786-b8cf-1685edb0853e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

20860936000352

Quantity per Package

5

Contains DI Package

00860936000358

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box