Catalog Number

CBN-114

Brand Name

CBN-114

Version/Model Number

11GA X 4"

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

K183146,K183146,K183146

Product Code

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

58f7a910-7b41-44a9-97b7-80f90e810edf

Public Version Date

August 08, 2019

Public Version Number

1

DI Record Publish Date

July 31, 2019

Package DI Number

20857878007648

Quantity per Package

80

Contains DI Package

10857878007641

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case