Catalog Number

70052

Brand Name

Trimedyne® R-50™ Spinal Introduction Cannula

Version/Model Number

70052

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

BSP

Product Code Name

Needle, Conduction, Anesthetic (W/Wo Introducer)

Public Device Record Key

f88183fe-ceb5-4f2e-bda9-77266d59670c

Public Version Date

February 27, 2020

Public Version Number

3

DI Record Publish Date

July 11, 2018

Package DI Number

M473700521

Quantity per Package

5

Contains DI Package

M473700520

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton