Expect Pulmonary - Endobronchial Ultrasound Transbronchial - BOSTON SCIENTIFIC CORPORATION

Duns Number:021717889

Device Description: Endobronchial Ultrasound Transbronchial Aspiration Needle

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More Product Details

Catalog Number

-

Brand Name

Expect Pulmonary

Version/Model Number

M00558250

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

EOQ

Product Code Name

BRONCHOSCOPE (FLEXIBLE OR RIGID)

Device Record Status

Public Device Record Key

3b1a003f-0bd1-4013-8396-58229ecae573

Public Version Date

July 12, 2019

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

08714729861447

Quantity per Package

5

Contains DI Package

08714729861416

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"BOSTON SCIENTIFIC CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 536
2 A medical device with a moderate to high risk that requires special controls. 8659
3 A medical device with high risk that requires premarket approval 1821
U Unclassified 35