Catalog Number

SP-3104-R

Brand Name

1.5MM SYSTEM

Version/Model Number

SP-3104-R

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 27, 2020

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

K121589

Product Code

JEY

Product Code Name

PLATE, BONE

Public Device Record Key

d26f66ce-4edc-4dc2-b338-dd478a6853f6

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

October 11, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-