AIDA compact - AIDA compact II Software Upgrade (v.2.4 - Karl Storz GmbH & Co. KG

Duns Number:315731430

Device Description: AIDA compact II Software Upgrade (v.2.4

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More Product Details

Catalog Number

-

Brand Name

AIDA compact

Version/Model Number

20040502-U02

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

K052159

Product Code Details

Product Code

LLZ

Product Code Name

System, image processing, radiological

Device Record Status

Public Device Record Key

1efbaf4d-72de-4a79-bbec-a17d57fadeaf

Public Version Date

July 06, 2018

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

-

"KARL STORZ GMBH & CO. KG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3584
2 A medical device with a moderate to high risk that requires special controls. 4864
3 A medical device with high risk that requires premarket approval 18