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

Duns Number:837845234

Device Description: Orthopedic surgical instrument - Radiographic ruler

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More Product Details

Catalog Number

XRR2-000

Brand Name

PRECICE® Instruments

Version/Model Number

XRR2-000

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

FTY

Product Code Name

Tape, Measuring, Rulers And Calipers

Device Record Status

Public Device Record Key

9f5a623c-a118-4ca8-a15d-fc21543a3882

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 30, 2017

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