Drive Rail System - 10 mm Ratchet Wrench - ORTHOPEDIATRICS CORP.

Duns Number:796416191

Device Description: 10 mm Ratchet Wrench

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More Product Details

Catalog Number

29-0020

Brand Name

Drive Rail System

Version/Model Number

29-0020

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

-

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

HXC

Product Code Name

WRENCH

Device Record Status

Public Device Record Key

daf0b94d-f2ad-4ea3-80c6-57f57216d40a

Public Version Date

June 27, 2022

Public Version Number

1

DI Record Publish Date

June 17, 2022

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