restor3d Reusable Instrument Tray/Kit - Reusable Instrument Tray/Kit, Osteotomy Wedge - Restor3d

Duns Number:080819836

Device Description: Reusable Instrument Tray/Kit, Osteotomy Wedge System

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


More Product Details

Catalog Number

-

Brand Name

restor3d Reusable Instrument Tray/Kit

Version/Model Number

5000-0401K

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

-

Product Code Details

Product Code

MDM

Product Code Name

Instrument, Manual, Surgical, General Use

Device Record Status

Public Device Record Key

94af4bc4-27dc-47d0-9345-0e7a5e046659

Public Version Date

July 08, 2021

Public Version Number

2

DI Record Publish Date

December 16, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RESTOR3D" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 156
2 A medical device with a moderate to high risk that requires special controls. 156