Catalog Number

-

Brand Name

Shiley

Version/Model Number

8888247023

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

K760125,K760125,K760125

Product Code

BTQ

Product Code Name

AIRWAY, NASOPHARYNGEAL

Public Device Record Key

c8d10a32-8827-43f0-a492-bf7ef9720f8d

Public Version Date

August 23, 2021

Public Version Number

1

DI Record Publish Date

August 15, 2021

Package DI Number

20884521815848

Quantity per Package

10

Contains DI Package

10884521815841

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK