Catalog Number

9770641

Brand Name

Pinpoint GT

Version/Model Number

9770641

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

BSP

Product Code Name

NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Public Device Record Key

93aa04cf-00b7-4c8c-906b-f78ca0da6a95

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 04, 2017

Package DI Number

30801741128869

Quantity per Package

4

Contains DI Package

10801741128865

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX