Catalog Number

PEEK-IM2001

Brand Name

Kelyniam CCI

Version/Model Number

PEEK-IM2001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 08, 2019

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

d1c2d35e-fa23-43fb-8ad2-1b77ebe2796f

Public Version Date

August 16, 2019

Public Version Number

1

DI Record Publish Date

August 08, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-