Chromophare - Berchtold Surgical Light System ? Mobile - Berchtold Holding GmbH

Duns Number:316153824

Device Description: Berchtold Surgical Light System ? Mobile

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More Product Details

Catalog Number

CM00000001

Brand Name

Chromophare

Version/Model Number

CM00000001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 13, 2021

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

FSS

Product Code Name

Light, surgical, floor standing

Device Record Status

Public Device Record Key

5c3bb5a5-1a28-4f4e-b10c-58914f17e26a

Public Version Date

October 13, 2021

Public Version Number

7

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