Drive Rail - Hinge, Low Overhang +5mm - ORTHOPEDIATRICS CORP.

Duns Number:796416191

Device Description: Hinge, Low Overhang +5mm

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More Product Details

Catalog Number

20-3505

Brand Name

Drive Rail

Version/Model Number

20-3505

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

7484c186-f1ed-4e3d-8996-d06800fc90ce

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