Catalog Number

-

Brand Name

Kera Ti5-Disc 99,5 x 20 mm

Version/Model Number

T10045120

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EJH

Product Code Name

Alloy, Metal, Base

Public Device Record Key

fa0a5a2f-b5f7-4d43-bceb-c26421eaa963

Public Version Date

February 14, 2020

Public Version Number

1

DI Record Publish Date

February 06, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-