Neuro Plating System - ALU Tray coated with PU (body + drawer + Lid) - OSTEONIC CO.,Ltd.

Duns Number:688999370

Device Description: ALU Tray coated with PU (body + drawer + Lid)

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Neuro Plating System

Version/Model Number

TPN-007

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

FSM

Product Code Name

Tray, Surgical, Instrument

Device Record Status

Public Device Record Key

4e5045d0-f655-4e1f-a669-920b755176e7

Public Version Date

September 16, 2022

Public Version Number

7

DI Record Publish Date

February 14, 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