Catalog Number

45000002

Brand Name

Vario-Soft 3 sv bridge-section

Version/Model Number

45000002

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 02, 2019

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

-

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

EGG

Product Code Name

ATTACHMENT, PRECISION, ALL

Public Device Record Key

8fa563de-8d59-4af7-9e0b-389483e82a6e

Public Version Date

April 03, 2019

Public Version Number

3

DI Record Publish Date

September 27, 2016

Package DI Number

EBRE450000029

Quantity per Package

1

Contains DI Package

EBRE450000020

Package Discontinue Date

September 27, 2016

Package Status

Not in Commercial Distribution

Package Type

dummy