Catalog Number

-

Brand Name

Sklar®

Version/Model Number

78-2012

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K981891

Product Code

BTO

Product Code Name

Tube, tracheostomy (w/wo connector)

Public Device Record Key

a6a02560-c77a-4a75-921f-08c7208b3dbd

Public Version Date

June 05, 2020

Public Version Number

4

DI Record Publish Date

September 08, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-