Catalog Number

PEEK-IM1004

Brand Name

Kelyniam CSI

Version/Model Number

PEEK-IM1004

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 23, 2021

Issuing Agency

In GS1

MRI safety Status

MR Safe

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K103582

Product Code

GXN

Product Code Name

Plate, Cranioplasty, Preformed, Non-Alterable

Public Device Record Key

15f2e8c0-ed0e-48a6-a3fb-6052eb89e7f7

Public Version Date

August 02, 2021

Public Version Number

1

DI Record Publish Date

July 23, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-