PRECICE® Instruments - Orthopedic surgical instrument - Guide tube - NUVASIVE SPECIALIZED ORTHOPEDICS, INC.

Duns Number:837845234

Device Description: Orthopedic surgical instrument - Guide tube

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

GTT2-000

Brand Name

PRECICE® Instruments

Version/Model Number

GTT2-000

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

K172061

Product Code Details

Product Code

HSB

Product Code Name

Rod, Fixation, Intramedullary And Accessories

Device Record Status

Public Device Record Key

6108ef3e-26bc-4926-ab11-cf565d2241c9

Public Version Date

April 06, 2020

Public Version Number

5

DI Record Publish Date

January 02, 2018

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