Catalog Number

PEEK-IM1002

Brand Name

Kelyniam CSI

Version/Model Number

PEEK-IM1002

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 29, 2020

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

a82b982b-c8b0-4681-9233-2e6987d67da4

Public Version Date

May 07, 2020

Public Version Number

1

DI Record Publish Date

April 29, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-