GRAFCO - Stainless Steel Sterilizer, Dry Heat - GF HEALTH PRODUCTS, INC.

Duns Number:132016168

Device Description: Stainless Steel Sterilizer, Dry Heat

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More Product Details

Catalog Number

-

Brand Name

GRAFCO

Version/Model Number

8376

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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 Details

Product Code

KMH

Product Code Name

Sterilizer, Dry Heat

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GF HEALTH PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1068
2 A medical device with a moderate to high risk that requires special controls. 202