VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM - REDUCE TRIAL, H-PLATE, 25MM - ORTHOFIX SRL

Duns Number:438793622

Device Description: REDUCE TRIAL, H-PLATE, 25MM

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More Product Details

Catalog Number

003-A-25008

Brand Name

VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM

Version/Model Number

1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K142135

Product Code Details

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Device Record Status

Public Device Record Key

460f2684-94b8-4645-9464-78aab762f6d7

Public Version Date

September 18, 2018

Public Version Number

5

DI Record Publish Date

June 07, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ORTHOFIX SRL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 64
2 A medical device with a moderate to high risk that requires special controls. 6371