Catalog Number

122040

Brand Name

SMARTPIN

Version/Model Number

122040

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 31, 2021

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

-

Product Code

HTY

Product Code Name

PIN, FIXATION, SMOOTH

Public Device Record Key

aed5a93e-88ff-435f-8e83-36805a1449c1

Public Version Date

September 01, 2021

Public Version Number

3

DI Record Publish Date

October 24, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-