Catalog Number

Sertera-14

Brand Name

Sertera Biopsy Device

Version/Model Number

Sertera-14

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"

-

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

K150169

Product Code

KNW

Product Code Name

INSTRUMENT, BIOPSY

Public Device Record Key

e8975db1-3560-41e5-a7e3-f72cc8bb0787

Public Version Date

July 12, 2019

Public Version Number

4

DI Record Publish Date

December 14, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-