SMARTDRAPE - Carl Zeiss Meditec AG

Duns Number:342228620

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More Product Details

Catalog Number

-

Brand Name

SMARTDRAPE

Version/Model Number

306028-0000-000

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

Yes

Prescription Use (Rx)

-

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

KKX

Product Code Name

Drape, Surgical

Device Record Status

Public Device Record Key

698f97e6-9421-4996-a237-2de0ca88c799

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 24, 2017

Additional Identifiers

Package DI Number

04049539102416

Quantity per Package

6

Contains DI Package

04049539102393

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"CARL ZEISS MEDITEC AG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 14
2 A medical device with a moderate to high risk that requires special controls. 86
3 A medical device with high risk that requires premarket approval 1