PediNail Intramedullary Platform - CAPTURED SCREW DRIVER SLEEVE, SHORT - ORTHOPEDIATRICS CORP.

Duns Number:796416191

Device Description: CAPTURED SCREW DRIVER SLEEVE, SHORT

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More Product Details

Catalog Number

01-1501-0038

Brand Name

PediNail Intramedullary Platform

Version/Model Number

01-1501-0038

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

LXH

Product Code Name

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Device Record Status

Public Device Record Key

8c7b1a56-30df-47b7-a964-0e29992206c2

Public Version Date

July 02, 2018

Public Version Number

1

DI Record Publish Date

May 31, 2018

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