Catalog Number

-

Brand Name

Adjustable Reconstruction Tube

Version/Model Number

ERT-14

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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"

Yes

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

KAC

Product Code Name

Tube, Laryngectomy

Public Device Record Key

425657ad-2eae-45c4-8095-28cccda1a2b1

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 12, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-