Catalog Number

-

Brand Name

Shiley

Version/Model Number

80XLTIN

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

405ac4df-ecb2-412b-9fa0-cf5e99ddad85

Public Version Date

June 24, 2022

Public Version Number

6

DI Record Publish Date

August 28, 2015

Package DI Number

60884522006748

Quantity per Package

10

Contains DI Package

50884522006741

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK