Catalog Number

43005670

Brand Name

Vario-Soft 3

Version/Model Number

43005670

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

-

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

af4f1898-cd86-4a94-90e0-e9e708eeba4c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 21, 2016

Package DI Number

EBRE430056709

Quantity per Package

1

Contains DI Package

EBRE430056700

Package Discontinue Date

September 21, 2016

Package Status

Not in Commercial Distribution

Package Type

dummy