Drive Rail - Standard Carriage - ORTHOPEDIATRICS CORP.

Duns Number:796416191

Device Description: Standard Carriage

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More Product Details

Catalog Number

21-2002

Brand Name

Drive Rail

Version/Model Number

21-2002

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 22, 2022

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

31939648-2368-4e94-94eb-b46525fe9877

Public Version Date

June 22, 2022

Public Version Number

5

DI Record Publish Date

December 13, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ORTHOPEDIATRICS CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1662
2 A medical device with a moderate to high risk that requires special controls. 7273