Catalog Number

1903

Brand Name

Curity

Version/Model Number

1903

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FRL

Product Code Name

FIBER, MEDICAL, ABSORBENT

Public Device Record Key

55fe0e38-a6d9-4961-99e1-97c7cfbc3ab6

Public Version Date

August 24, 2021

Public Version Number

3

DI Record Publish Date

June 22, 2018

Package DI Number

30884521058587

Quantity per Package

2400

Contains DI Package

10884521058583

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE