Catalog Number

477501000

Brand Name

aScope™ 4 Broncho Regular Sampler Set 5.0/2.2

Version/Model Number

477501000

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

-

Product Code

EOQ

Product Code Name

Bronchoscope (flexible or rigid)

Public Device Record Key

362ab42e-327c-470b-8842-c90ea80a1ec9

Public Version Date

September 24, 2021

Public Version Number

1

DI Record Publish Date

September 16, 2021

Package DI Number

05707480145966

Quantity per Package

4

Contains DI Package

05707480145973

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-