Catalog Number

-

Brand Name

GRAFCO

Version/Model Number

C101

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

IMD

Product Code Name

Pack, Hot Or Cold, Disposable

Public Device Record Key

1436f428-96d7-43a5-b3e6-97827701156a

Public Version Date

September 02, 2020

Public Version Number

1

DI Record Publish Date

August 25, 2020

Package DI Number

M368C1012

Quantity per Package

24

Contains DI Package

M368C1011

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box