Catalog Number

8001-061-530

Brand Name

Rapr-Round

Version/Model Number

8001-061-530

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

-

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

K100585,K100585

Product Code

DWJ

Product Code Name

System, thermal regulating

Public Device Record Key

66d5c28f-3440-4c94-bc7c-ac8d8b676a6f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

57613327175085

Quantity per Package

5

Contains DI Package

07613327175080

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case