Catalog Number

3967

Brand Name

Curity

Version/Model Number

3967

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

f2e2def7-e1fa-4a65-bfda-070487f4d5c1

Public Version Date

August 24, 2021

Public Version Number

3

DI Record Publish Date

June 27, 2018

Package DI Number

30884521058945

Quantity per Package

800

Contains DI Package

10884521058941

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE