NA - ZEISS NC4 MICRO.NAV.SYS. II SET - Stryker Leibinger GmbH & Co. KG

Duns Number:316153956

Device Description: ZEISS NC4 MICRO.NAV.SYS. II SET

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More Product Details

Catalog Number

7700-054-000

Brand Name

NA

Version/Model Number

7700-054-000

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

-

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

HAW

Product Code Name

Neurological stereotaxic Instrument

Device Record Status

Public Device Record Key

e853b804-3ea8-441b-b30d-c267655dab12

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STRYKER LEIBINGER 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 777
2 A medical device with a moderate to high risk that requires special controls. 2520