NA - 3D ORBITAL FLOOR PLATE, RIGHT, LARGE - Stryker Leibinger GmbH & Co. KG

Duns Number:316153956

Device Description: 3D ORBITAL FLOOR PLATE, RIGHT, LARGE

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More Product Details

Catalog Number

54-04005

Brand Name

NA

Version/Model Number

54-04005

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K123786

Product Code Details

Product Code

JEY

Product Code Name

PLATE, BONE

Device Record Status

Public Device Record Key

04afc3e9-953f-4437-954b-5a66819cfb27

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

October 09, 2015

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