Catalog Number

2438G

Brand Name

Curity

Version/Model Number

2438G

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

a6e2583e-9339-4d6d-8c3f-dca636815456

Public Version Date

August 24, 2021

Public Version Number

3

DI Record Publish Date

November 14, 2019

Package DI Number

50885380173484

Quantity per Package

10

Contains DI Package

20885380173483

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE