Catalog Number

5010

Brand Name

TruLim Length Indicating Device

Version/Model Number

5010

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

FTY

Product Code Name

Tape, Measuring, Rulers And Calipers

Public Device Record Key

6e8c30e6-be57-4e1b-8602-0e5ab5489945

Public Version Date

June 29, 2022

Public Version Number

1

DI Record Publish Date

June 21, 2022

Package DI Number

40816286021084

Quantity per Package

6

Contains DI Package

10816286021083

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box