Catalog Number

-

Brand Name

Schon

Version/Model Number

10800702

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"

-

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

-

Product Code

LFJ

Product Code Name

CATHETER, SUBCLAVIAN

Public Device Record Key

68c48ade-e9ba-48d4-9d7f-e10439d96846

Public Version Date

November 03, 2021

Public Version Number

4

DI Record Publish Date

September 15, 2015

Package DI Number

H787108007025

Quantity per Package

5

Contains DI Package

H787108007020

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX