AccessGUDID - DEVICE: Axis Spine Technologies ALIF System Instrument (05060771806336)

GUDID

Device Identifier (DI) Information

Brand Name: Axis Spine Technologies ALIF System Instrument
Version or Model: A6060675
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A6060675
Company Name: AXIS SPINE TECHNOLOGIES LTD

Primary DI Number: 05060771806336
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 221947288 *Terms of Use

Device Description: ALIF Core Trial - 6x25

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?
44788	Spinal implant trial	A copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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: b9cc2ccf-b17a-45db-9908-2a737c02a626
Public Version Date: May 24, 2023
Public Version Number: 1
DI Record Publish Date: May 16, 2023