Catalog Number

-

Brand Name

PUMA SYSTEM

Version/Model Number

GEN 3

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K171703

Product Code

HTN

Product Code Name

Washer, Bolt Nut

Public Device Record Key

1a4b9de8-b02d-4597-936d-c0d563c2d22b

Public Version Date

February 21, 2020

Public Version Number

1

DI Record Publish Date

February 13, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-