Catalog Number

INS-5300

Brand Name

Always-On Tip Tracked Triple Needle Brush, 12mm L, 1.8mm OD

Version/Model Number

INS-5300

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

K170023,K170023

Product Code

JAK

Product Code Name

System, X-Ray, Tomography, Computed

Public Device Record Key

728581a3-11ef-4319-8063-ca71c03c83a7

Public Version Date

March 28, 2022

Public Version Number

3

DI Record Publish Date

October 11, 2019

Package DI Number

00815686021214

Quantity per Package

5

Contains DI Package

00815686021207

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-