Archimedies Access Kit with Syringe - A collection of sterile devices designed to - BRONCUS MEDICAL INC.

Duns Number:078684808

Device Description: A collection of sterile devices designed to access and perform a biopsy sample during a lu A collection of sterile devices designed to access and perform a biopsy sample during a lung biopsy.

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More Product Details

Catalog Number

10009-09

Brand Name

Archimedies Access Kit with Syringe

Version/Model Number

12196-09

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

K131234

Product Code Details

Product Code

EOQ

Product Code Name

Bronchoscope (Flexible Or Rigid)

Device Record Status

Public Device Record Key

093a6a0b-4e29-4a55-bd42-4a8492690034

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 14, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BRONCUS MEDICAL INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 14