Catalog Number

9A10111

Brand Name

PinPoint

Version/Model Number

9A10111

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"

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

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Public Device Record Key

c7ca6711-8196-44a3-9f7c-b53d4d23829e

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

10801741091213

Quantity per Package

50

Contains DI Package

00801741091216

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA