Catalog Number

INS-5600

Brand Name

SPiNPerc Biopsy Needle Guide Kit

Version/Model Number

INS-5600

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

cd3c591f-5699-40a5-a67f-7b5c0883d9ff

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 31, 2016

Package DI Number

10815686020733

Quantity per Package

5

Contains DI Package

00815686020736

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-