Catalog Number

-

Brand Name

GRAFCO

Version/Model Number

8376

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K771070

Product Code

KMH

Product Code Name

Sterilizer, Dry Heat

Public Device Record Key

edc56da7-0a8a-4ade-b0f9-86a1d5dc404e

Public Version Date

September 01, 2020

Public Version Number

1

DI Record Publish Date

August 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-