Catalog Number

SOP-1033

Brand Name

2.0 mm Inion CPS®

Version/Model Number

1

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

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

K010352

Product Code

JEY

Product Code Name

PLATE, BONE

Public Device Record Key

35d5e6c7-a3ea-4c82-a2d4-b5e81a6ecc25

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

February 07, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-