ClearView - ClearView Endoscopic Ultrasound Needle, EUS-FNA, - Medi-Globe GmbH

Duns Number:318130267

Device Description: ClearView Endoscopic Ultrasound Needle, EUS-FNA, 25 G, Needle Length 0 - 8.5 cm, Sheath Di ClearView Endoscopic Ultrasound Needle, EUS-FNA, 25 G, Needle Length 0 - 8.5 cm, Sheath Diameter 1.8 mm, round stylet

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More Product Details

Catalog Number

CV1825R

Brand Name

ClearView

Version/Model Number

CV1825R

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

FCG

Product Code Name

Biopsy Needle

Device Record Status

Public Device Record Key

ffdb0d8f-d601-4fb2-baf9-0c6d96f28fab

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

4052838015738

Quantity per Package

5

Contains DI Package

04052838015721

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"MEDI-GLOBE GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 51