Catalog Number

-

Brand Name

Single Use Guide Sheath Kit

Version/Model Number

K-401

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K212667,K212667

Product Code

BTG

Product Code Name

Brush, Biopsy, Bronchoscope (Non-Rigid)

Public Device Record Key

991ff4bb-b129-424a-8c85-f8c26999ec3a

Public Version Date

September 05, 2022

Public Version Number

2

DI Record Publish Date

November 05, 2021

Package DI Number

14953170408981

Quantity per Package

1

Contains DI Package

04953170408984

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-