Catalog Number

ULSEC1115C

Brand Name

BIOPSYBELL

Version/Model Number

UNLUX SYSTEM

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K130616

Product Code

FCG

Product Code Name

Biopsy Needle

Public Device Record Key

08bba3d2-48fa-46e9-bee0-135b89c3e849

Public Version Date

March 22, 2021

Public Version Number

1

DI Record Publish Date

March 12, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-