Catalog Number

-

Brand Name

Cradles

Version/Model Number

309

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KGX

Product Code Name

Tape And Bandage, Adhesive

Public Device Record Key

6a6badc7-69b9-4d76-a2de-b0c80fb3d86d

Public Version Date

October 23, 2019

Public Version Number

2

DI Record Publish Date

July 22, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-