Catalog Number

-

Brand Name

ORIA XENA® Top Clip System

Version/Model Number

C070-6005

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

-

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

K040346

Product Code

HWJ

Product Code Name

AWL

Public Device Record Key

ef5c45c2-1136-46a1-90f3-2d08b4a7ce46

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 12, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-