Neuro Plating System - Rectangular Plate, Middle, 4Hole - OSTEONIC CO.,Ltd.

Duns Number:688999370

Device Description: Rectangular Plate, Middle, 4Hole

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More Product Details

Catalog Number

-

Brand Name

Neuro Plating System

Version/Model Number

NRE304M04A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

K141911,K190811

Product Code Details

Product Code

GWO

Product Code Name

Plate, Cranioplasty, Preformed, Alterable

Device Record Status

Public Device Record Key

a5353557-b23e-4b32-a147-e994749e7def

Public Version Date

February 05, 2020

Public Version Number

3

DI Record Publish Date

February 13, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OSTEONIC CO.,LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 26
2 A medical device with a moderate to high risk that requires special controls. 218