P.L.U.S.® - Screwdriver for Multi-axial Screws - SPINEVISION

Duns Number:390377518

Device Description: Screwdriver for Multi-axial Screws

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More Product Details

Catalog Number

-

Brand Name

P.L.U.S.®

Version/Model Number

U1-A236

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

HXX

Product Code Name

SCREWDRIVER

Device Record Status

Public Device Record Key

cd1094dc-0f16-4d12-bab5-6d94458b6f23

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 21, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SPINEVISION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 603
2 A medical device with a moderate to high risk that requires special controls. 1751