AccessGUDID - DEVICE: Irix-A Lumbar Integrated Fusion System (M697T080010091)

GUDID

Device Identifier (DI) Information

Brand Name: Irix-A Lumbar Integrated Fusion System
Version or Model: T080-0100-9
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Xtant Medical Holdings, Inc.

Primary DI Number: M697T080010091
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081224143 *Terms of Use

Device Description: Irix A 4mm Anterior Kerrison Rongeur

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35541	Spinal rongeur	A hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (intervertebral disk) or bone, through a cutting/biting action, during open spinal surgery (e.g., laminectomy, discectomy). It is typically made of metal and designed to withstand the forces required to bite over tough tissue. It is not intended for endoscopic access. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HTX	RONGEUR

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Width: 4 Millimeter

Device Record Status

Public Device Record Key: c28d50dc-695c-4797-bcf7-e64107d3bf3d
Public Version Date: November 14, 2024
Public Version Number: 5
DI Record Publish Date: October 30, 2015