Catalog Number

-

Brand Name

Tube set for irrigation, single-use

Version/Model Number

INFLWTBING

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

313b009d-e91b-43a1-aba1-70a737af9172

Public Version Date

November 09, 2020

Public Version Number

1

DI Record Publish Date

November 01, 2020

Package DI Number

04056702008864

Quantity per Package

10

Contains DI Package

04056702008857

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-