Catalog Number

-

Brand Name

Shiley

Version/Model Number

60XLTIN

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

K051416,K051416,K051416

Product Code

JOH

Product Code Name

Tube tracheostomy and tube cuff

Public Device Record Key

0438d86a-c811-4f09-b4f5-4492b136124e

Public Version Date

October 31, 2022

Public Version Number

7

DI Record Publish Date

August 28, 2015

Package DI Number

50884522006727

Quantity per Package

10

Contains DI Package

40884522006720

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE