Catalog Number

SSI003363

Brand Name

ALPS

Version/Model Number

SSI003363

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

-

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

K132898

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Public Device Record Key

1ee4b802-8b7b-4aab-a66e-d2868d66412d

Public Version Date

April 06, 2020

Public Version Number

3

DI Record Publish Date

September 12, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-