AccessGUDID - DEVICE: H-Graft Interspinous Allograft (M697C07800241)

GUDID

Device Identifier (DI) Information

Brand Name: H-Graft Interspinous Allograft
Version or Model: C078-0024
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Xtant Medical Holdings, Inc.

Primary DI Number: M697C07800241
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081224143 *Terms of Use

Device Description: Special Instrument, H-Graft Dorsal Inserter, Interspinous Cortical Block Assembly

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:	Yes
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?
47938	Cadaveric-donor bone allograft	A bone tissue graft harvested from a cadaveric human donor intended for transplantation to provide body mass and structural/mechanical support. It is typically disinfected and frozen for storage prior to implantation.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HWA	Impactor

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
No Device Sizes

Device Record Status

Public Device Record Key: 506d5bf7-dcf8-4980-b853-3a8b59bafed4
Public Version Date: June 10, 2022
Public Version Number: 3
DI Record Publish Date: May 19, 2021