Catalog Number

C100F

Brand Name

Cultura™

Version/Model Number

00884450491102

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

KXG

Product Code Name

APPLICATOR, ABSORBENT TIPPED, STERILE

Public Device Record Key

32520f07-1910-4cd8-b35e-b400e2b505ac

Public Version Date

July 22, 2021

Public Version Number

3

DI Record Publish Date

May 19, 2020

Package DI Number

20884450491106

Quantity per Package

4

Contains DI Package

10884450491109

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-