Ulna Shortening Plating System - SKELETAL DYNAMICS L.L.C.

Duns Number:869056148

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More Product Details

Catalog Number

USP-DRS

Brand Name

Ulna Shortening Plating System

Version/Model Number

Ulnar Shortening Plate, Distal, Short, Right

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

K201962

Product Code Details

Product Code

HRS

Product Code Name

Plate, fixation, bone

Device Record Status

Public Device Record Key

e61047f2-7076-4105-bf70-c6965aec44c1

Public Version Date

December 03, 2020

Public Version Number

1

DI Record Publish Date

November 25, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SKELETAL DYNAMICS L.L.C." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 818