PRECICE® Trauma Nail System - Curved Cannulated Awl - NUVASIVE SPECIALIZED ORTHOPEDICS, INC.

Duns Number:837845234

Device Description: Curved Cannulated Awl

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More Product Details

Catalog Number

AWL1-000

Brand Name

PRECICE® Trauma Nail System

Version/Model Number

AWL1-000

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

HWJ

Product Code Name

Awl

Device Record Status

Public Device Record Key

fc735b93-661b-44ad-9d75-bb5125eaee9c

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

October 06, 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