Flexible Video Bronchoscope (NTSC) Reconditioned - Reconditioned - COGENTIX MEDICAL, INC.

Duns Number:780024725

Device Description: Reconditioned

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More Product Details

Catalog Number

04-5203P

Brand Name

Flexible Video Bronchoscope (NTSC) Reconditioned

Version/Model Number

BRS-5100

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 26, 2018

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"

Yes

For Single-Use

-

Prescription Use (Rx)

-

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

653d2144-8145-4b72-8d2b-d041de5dc318

Public Version Date

July 02, 2019

Public Version Number

4

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"COGENTIX 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. 33