Catalog Number

31-705

Brand Name

DeRoyal

Version/Model Number

31-705

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

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

2646366c-9d32-4dfc-8155-ed7df4b65ca5

Public Version Date

August 31, 2021

Public Version Number

1

DI Record Publish Date

August 23, 2021

Package DI Number

50749756371280

Quantity per Package

800

Contains DI Package

00749756371285

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case