Catalog Number

-

Brand Name

Shiley

Version/Model Number

10DICFEN

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

K962173,K962173,K962173

Product Code

JOH

Product Code Name

Tube tracheostomy and tube cuff

Public Device Record Key

a1c4ec0f-483c-4e3a-8226-2f085cb07a2a

Public Version Date

June 21, 2022

Public Version Number

5

DI Record Publish Date

August 28, 2015

Package DI Number

50884522005218

Quantity per Package

10

Contains DI Package

60884522005215

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK