Catalog Number

-

Brand Name

PATTERSON

Version/Model Number

070847004

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

-

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

K930764,K930764

Product Code

EAT

Product Code Name

Tester, Pulp

Public Device Record Key

68b70be3-0b81-442e-aaf8-aa21adcbb3b9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

D6620708470044

Quantity per Package

12

Contains DI Package

D6620708470040

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CAN