Catalog Number

PD-04-470

Brand Name

CORUS Guide Tube Adapter

Version/Model Number

PD-04-470

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

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Public Device Record Key

da98b8de-7b10-4683-9017-a8c8a1c58b11

Public Version Date

September 16, 2022

Public Version Number

2

DI Record Publish Date

March 01, 2021

Package DI Number

10852776006512

Quantity per Package

1

Contains DI Package

00852776006515

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box