SICAT FUNCTION - SiCAT GmbH & Co. KG

Duns Number:333707003

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More Product Details

Catalog Number

-

Brand Name

SICAT FUNCTION

Version/Model Number

V2.0

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 02, 2021

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

K133320

Product Code Details

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Device Record Status

Public Device Record Key

1506c29d-04b1-47c8-90c2-44aad180dbc9

Public Version Date

July 05, 2021

Public Version Number

2

DI Record Publish Date

September 08, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SICAT 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 2
2 A medical device with a moderate to high risk that requires special controls. 20
U Unclassified 1