Catalog Number

9004597

Brand Name

Henry Schein

Version/Model Number

9004597

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"

-

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

-

Product Code

ELW

Product Code Name

MATERIAL, IMPRESSION

Public Device Record Key

b8529e4e-c2c0-47c8-a96c-b94f62f5c1d8

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Package DI Number

10304040003869

Quantity per Package

8

Contains DI Package

00304040003862

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE