Catalog Number

-

Brand Name

Tube set for suction, single-use

Version/Model Number

OTFLWTBING2

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

-

Product Code

HET

Product Code Name

Laparoscope, Gynecologic (And Accessories)

Public Device Record Key

c86aa1e2-1955-4c63-8177-049f35f2810e

Public Version Date

July 04, 2022

Public Version Number

2

DI Record Publish Date

November 01, 2020

Package DI Number

04056702008826

Quantity per Package

10

Contains DI Package

04056702008819

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-