Chromophare F300 - Berchtold Examination Light ? Mobile - Berchtold Holding GmbH

Duns Number:316153824

Device Description: Berchtold Examination Light ? Mobile

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


More Product Details

Catalog Number

CF 2893075

Brand Name

Chromophare F300

Version/Model Number

CF2893075

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)

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

KZF

Product Code Name

DEVICE, MEDICAL EXAMINATION, AC POWERED

Device Record Status

Public Device Record Key

57838a81-ddce-4b56-9f52-806a74f3a119

Public Version Date

January 08, 2021

Public Version Number

3

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BERCHTOLD HOLDING GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 102
2 A medical device with a moderate to high risk that requires special controls. 2