SIDEKICK - WRIGHT MEDICAL TECHNOLOGY, INC.

Duns Number:807201207

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More Product Details

Catalog Number

RR2000PK

Brand Name

SIDEKICK

Version/Model Number

RR2000PK

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

-

Product Code Details

Product Code

KTT

Product Code Name

APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Device Record Status

Public Device Record Key

cc7fa0a9-7d6c-495c-93c4-54e5b2a112e9

Public Version Date

March 24, 2022

Public Version Number

4

DI Record Publish Date

January 29, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WRIGHT MEDICAL TECHNOLOGY, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1994
2 A medical device with a moderate to high risk that requires special controls. 5554