Drive Rail - Rotating Rail Endcap, 100mm - ORTHOPEDIATRICS CORP.

Duns Number:796416191

Device Description: Rotating Rail Endcap, 100mm

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More Product Details

Catalog Number

21-2001

Brand Name

Drive Rail

Version/Model Number

21-2001

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

fe037335-684c-4047-8d7d-dc0cffe339b0

Public Version Date

June 22, 2022

Public Version Number

4

DI Record Publish Date

May 30, 2019

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