Catalog Number

-

Brand Name

IMEDICOM HIGH SPEED BLADE

Version/Model Number

NSR-515

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HTT

Product Code Name

Burr, Orthopedic

Public Device Record Key

cd944521-b578-4629-8457-89d6d9aa4188

Public Version Date

August 20, 2020

Public Version Number

3

DI Record Publish Date

July 13, 2018

Package DI Number

08800038023659

Quantity per Package

10

Contains DI Package

08809288932216

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-