ORTHO SOLUTIONS ULTOS PLATING SYSTEM - UltOS 3.5MM LOCKING SCREW 20MM - ORTHO SOLUTIONS HOLDINGS LIMITED

Duns Number:218648211

Device Description: UltOS 3.5MM LOCKING SCREW 20MM

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More Product Details

Catalog Number

OS421720-NS

Brand Name

ORTHO SOLUTIONS ULTOS PLATING SYSTEM

Version/Model Number

OS421720-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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K141784

Product Code Details

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Device Record Status

Public Device Record Key

4fccba79-bb0f-48a5-81c6-4fcbdc04da32

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 28, 2016

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