Catalog Number

SLT-1055

Brand Name

Singer Laryngectomy Tube

Version/Model Number

SLT-1055

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

ce3a2069-c00e-476f-acd5-1e5b1b8d17e6

Public Version Date

August 30, 2022

Public Version Number

4

DI Record Publish Date

September 20, 2015

Package DI Number

EBESSLT10551

Quantity per Package

1

Contains DI Package

EBESSLT10550

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton