EDITOR HFe - EDITOR HFe401 0.96m US 1P IFC - Spellman High Voltage Electronics GmbH

Duns Number:342494647

Device Description: EDITOR HFe401 0.96m US 1P IFC

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


More Product Details

Catalog Number

091230104-IFC

Brand Name

EDITOR HFe

Version/Model Number

401

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)

Yes

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

IZO

Product Code Name

Generator, High-Voltage, X-Ray, Diagnostic

Device Record Status

Public Device Record Key

ead0d292-8ba8-401b-b09d-89f8d748c675

Public Version Date

July 16, 2018

Public Version Number

1

DI Record Publish Date

June 13, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SPELLMAN HIGH VOLTAGE ELECTRONICS GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 52