Catalog Number

PP9037

Brand Name

Pinpoint

Version/Model Number

PP9037

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

Yes

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

-

FDA Premarket Submission

K182606,K182606

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

372d8479-a577-4b8f-9f4e-378770f32de9

Public Version Date

August 07, 2019

Public Version Number

1

DI Record Publish Date

July 30, 2019

Package DI Number

37613327502801

Quantity per Package

6

Contains DI Package

07613327502800

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack