Volition™ Plating System - T10 SCREWDRIVER BIT, SELF-RETAINING - ORTHO SOLUTIONS HOLDINGS LIMITED

Duns Number:218648211

Device Description: T10 SCREWDRIVER BIT, SELF-RETAINING

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More Product Details

Catalog Number

OS721010-NS

Brand Name

Volition™ Plating System

Version/Model Number

OS721010-NS

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K202764

Product Code Details

Product Code

HXX

Product Code Name

Screwdriver

Device Record Status

Public Device Record Key

98d4464b-d8d8-4edb-84d1-ba2668204a0d

Public Version Date

July 05, 2021

Public Version Number

1

DI Record Publish Date

June 25, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ORTHO SOLUTIONS HOLDINGS LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 262
2 A medical device with a moderate to high risk that requires special controls. 1530