Catalog Number

-

Brand Name

ClearTip

Version/Model Number

FM-CTB001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

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

K180363,K180363

Product Code

FCG

Product Code Name

Biopsy Needle

Public Device Record Key

aa7f8ab8-619b-47d3-9cfb-8328869ef0a8

Public Version Date

July 12, 2019

Public Version Number

2

DI Record Publish Date

April 12, 2019

Package DI Number

18809327352958

Quantity per Package

1

Contains DI Package

08809327352951

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box