Catalog Number

1297

Brand Name

QUAKE

Version/Model Number

1297

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

-

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

K974849,K974849

Product Code

BYI

Product Code Name

Percussor, Powered-Electric

Public Device Record Key

5834dc95-4c27-4d63-a6aa-e417024a29e6

Public Version Date

June 22, 2021

Public Version Number

4

DI Record Publish Date

September 21, 2016

Package DI Number

10383480000065

Quantity per Package

5

Contains DI Package

00383480000068

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE