PRECICE® Intramedullary Limb Lengthening System Instrument - Orthopedic surgical instrument - for use with the - NUVASIVE SPECIALIZED ORTHOPEDICS, INC.

Duns Number:837845234

Device Description: Orthopedic surgical instrument - for use with the intramedullary limb lengthening system

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More Product Details

Catalog Number

AWA1-000

Brand Name

PRECICE® Intramedullary Limb Lengthening System Instrument

Version/Model Number

AWA1-000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

dab32419-3a1d-4ebe-8520-355527484e30

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 15, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NUVASIVE SPECIALIZED ORTHOPEDICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 254
2 A medical device with a moderate to high risk that requires special controls. 2199