PRECICE® Intramedullary Limb Lengthening System Instrument - Orthopedic surgical instrument (cannulated - NUVASIVE SPECIALIZED ORTHOPEDICS, INC.

Duns Number:837845234

Device Description: Orthopedic surgical instrument (cannulated driver) - for use with the intramedullary limb Orthopedic surgical instrument (cannulated driver) - for use with the intramedullary limb lengthening system

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More Product Details

Catalog Number

TCD1-000

Brand Name

PRECICE® Intramedullary Limb Lengthening System Instrument

Version/Model Number

TCD1-000

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

HWR

Product Code Name

Driver, Prosthesis

Device Record Status

Public Device Record Key

7c59455f-b956-46cb-9ecd-61e89e8451d4

Public Version Date

August 09, 2018

Public Version Number

3

DI Record Publish Date

February 05, 2016

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