Catalog Number

-

Brand Name

Tube set for vacuum incl. filter, 30-day use

Version/Model Number

INTUBWVACC

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K173489,K173489

Product Code

HET

Product Code Name

Laparoscope, Gynecologic (And Accessories)

Public Device Record Key

c0f2aa3e-f7bb-4dfe-98a9-32f27f4dfd22

Public Version Date

July 04, 2022

Public Version Number

2

DI Record Publish Date

November 01, 2020

Package DI Number

04056702008888

Quantity per Package

10

Contains DI Package

04056702008871

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-