Catalog Number

5750

Brand Name

Curity

Version/Model Number

5750

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

LKB

Product Code Name

Pad, alcohol, device disinfectant

Public Device Record Key

3042600b-12dd-4aa4-ab08-c0900005ee76

Public Version Date

June 10, 2021

Public Version Number

6

DI Record Publish Date

June 30, 2018

Package DI Number

30884527020625

Quantity per Package

4000

Contains DI Package

40884527020622

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE