Orthopediatrics Instrumentation - 3.2mm SCFE Wire Guide Inserter, Long - ORTHOPEDIATRICS CORP.

Duns Number:796416191

Device Description: 3.2mm SCFE Wire Guide Inserter, Long

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More Product Details

Catalog Number

01-1402-0010

Brand Name

Orthopediatrics Instrumentation

Version/Model Number

01-1402-0010

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

FZX

Product Code Name

Guide, surgical, instrument

Device Record Status

Public Device Record Key

49adb828-9b7f-4e4e-b4e8-143375da6787

Public Version Date

March 23, 2020

Public Version Number

1

DI Record Publish Date

March 13, 2020

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