Catalog Number

-

Brand Name

1.2X310MM SINGLE TROCAR

Version/Model Number

OL31012S

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

-

Product Code

HTY

Product Code Name

Pin, Fixation, Smooth

Public Device Record Key

de1c73c4-8dd5-419a-8b82-7e192cbfe972

Public Version Date

June 20, 2019

Public Version Number

1

DI Record Publish Date

June 12, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-