Irix-A Lumbar Integrated Fusion System - Special Instrument Size 2 (-0112) Push Cutting - Xtant Medical Holdings, Inc.

Duns Number:081224143

Device Description: Special Instrument Size 2 (-0112) Push Cutting Curette

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


More Product Details

Catalog Number

-

Brand Name

Irix-A Lumbar Integrated Fusion System

Version/Model Number

C080-0112

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

HTF

Product Code Name

Curette

Device Record Status

Public Device Record Key

0eeca9c9-e8da-4dc9-880f-004d47b5a100

Public Version Date

August 24, 2021

Public Version Number

3

DI Record Publish Date

May 19, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"XTANT MEDICAL HOLDINGS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1719
2 A medical device with a moderate to high risk that requires special controls. 3162
U Unclassified 25