Compass International - Disposable Biopsy Needle Removable Depth Stop - Compass International

Duns Number:809466410

Device Description: Disposable Biopsy Needle Removable Depth Stop

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More Product Details

Catalog Number

DBN-30-10

Brand Name

Compass International

Version/Model Number

DBN-30-10

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

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

4860cf6d-ac64-4741-9224-17541dece59e

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 07, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"COMPASS INTERNATIONAL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 41