Eleganza 3 - Basic electric hospital bed - L I N E T spol. s r.o.

Duns Number:644544504

Device Description: Basic electric hospital bed

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Eleganza 3

Version/Model Number

1GZA100-23

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

6388c63b-4cfc-4135-925e-e6b9262fc459

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

March 01, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"L I N E T SPOL. S R.O." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 196