VACU-CUT® - VACU-CUT® Disposable Aspiration Biopsy Needle 21g - Angiomed GmbH & Co. Medizintechnik KG

Duns Number:320047483

Device Description: VACU-CUT® Disposable Aspiration Biopsy Needle 21g x 200mm

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More Product Details

Catalog Number

17610080

Brand Name

VACU-CUT®

Version/Model Number

17610080

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

GAA

Product Code Name

NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Device Record Status

Public Device Record Key

b4c2eb7c-0490-4ecf-a22a-c2d0ab9c852c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 06, 2016

Additional Identifiers

Package DI Number

10801741083850

Quantity per Package

10

Contains DI Package

00801741083853

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA

"ANGIOMED GMBH & CO. MEDIZINTECHNIK KG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 32
2 A medical device with a moderate to high risk that requires special controls. 8
3 A medical device with high risk that requires premarket approval 174