Catalog Number

0056000

Brand Name

Adult Lopez Valve®

Version/Model Number

0056000

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K915171,K915171

Product Code

KNT

Product Code Name

TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Public Device Record Key

c23077f9-304d-4237-acc7-b026c5947eb5

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 06, 2016

Package DI Number

10801741052368

Quantity per Package

50

Contains DI Package

00801741052361

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA