Catalog Number

63.00.201

Brand Name

Tulips Size L

Version/Model Number

63.00.201

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HFS

Product Code Name

Shield, Nipple

Public Device Record Key

dc1aa1b9-3ad9-4544-b627-27973487839b

Public Version Date

August 07, 2020

Public Version Number

2

DI Record Publish Date

September 24, 2018

Package DI Number

00814079020193

Quantity per Package

24

Contains DI Package

00814079020186

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box