Versatech 600 2.0 - Usine Rotec Inc

Duns Number:245707815

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More Product Details

Catalog Number

-

Brand Name

Versatech 600 2.0

Version/Model Number

V600 2.0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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 Details

Product Code

FNL

Product Code Name

Bed, Ac-Powered Adjustable Hospital

Device Record Status

Public Device Record Key

10d84b7b-88c0-43c8-9811-87606817f2c8

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"USINE ROTEC INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 12