Buzz Virtual App - Brainlab AG

Duns Number:314482980

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More Product Details

Catalog Number

-

Brand Name

Buzz Virtual App

Version/Model Number

1.1

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"

Yes

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

LMD

Product Code Name

System, Digital Image Communications, Radiological

Device Record Status

Public Device Record Key

78ee3ab5-0e8a-4df0-b636-e3df32a5f2e4

Public Version Date

March 15, 2022

Public Version Number

1

DI Record Publish Date

March 07, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BRAINLAB AG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 48
2 A medical device with a moderate to high risk that requires special controls. 685