Catalog Number

-

Brand Name

Jelco

Version/Model Number

FC00

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

7624628e-d54a-49f8-b05a-13e7ce6c014c

Public Version Date

May 14, 2020

Public Version Number

1

DI Record Publish Date

May 06, 2020

Package DI Number

35019315057889

Quantity per Package

20

Contains DI Package

05019315057888

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton