Catalog Number

INS-5700

Brand Name

SPiN EWC – Biopsy Guide Kit

Version/Model Number

INS-5700

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K122106,K122106

Product Code

JAK

Product Code Name

System, X-Ray, Tomography, Computed

Public Device Record Key

b761ba9a-06ab-47b4-a403-a4cad53f837f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 31, 2016

Package DI Number

10815686021105

Quantity per Package

5

Contains DI Package

00815686021108

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-