Catalog Number

1018635

Brand Name

Henry Schein

Version/Model Number

1018635

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EMI

Product Code Name

FILE, BONE, SURGICAL

Public Device Record Key

0b703c8e-566b-4bfa-a8f8-6401fc645bd5

Public Version Date

September 25, 2019

Public Version Number

1

DI Record Publish Date

September 17, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-