Catalog Number

-

Brand Name

Jelco

Version/Model Number

HC12

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FYH

Product Code Name

SPLINT, EXTREMITY, NONINFLATABLE, EXTERNAL, STERILE

Public Device Record Key

ffed9fa4-035d-42de-b76c-2c2c2b77798e

Public Version Date

April 03, 2020

Public Version Number

1

DI Record Publish Date

March 26, 2020

Package DI Number

35019315057964

Quantity per Package

20

Contains DI Package

15019315057960

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton