Catalog Number

1100353-001

Brand Name

Bur PM2-70 80K steel Ø1.0mm sterile

Version/Model Number

1100353

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

Yes

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

EQJ

Product Code Name

Bur, Ear, Nose And Throat

Public Device Record Key

fb9b18c5-2a90-4cf4-8553-c84c2edcf01e

Public Version Date

February 08, 2019

Public Version Number

1

DI Record Publish Date

January 08, 2019

Package DI Number

J00711003530051

Quantity per Package

5

Contains DI Package

J00711003530011

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box