AccessGUDID - DEVICE: Axis Spine Technologies ALIF System Instrument (05056619801403)

GUDID

Device Identifier (DI) Information

Brand Name: Axis Spine Technologies ALIF System Instrument
Version or Model: 2984 30 310
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2984 30 310
Company Name: AXIS SPINE TECHNOLOGIES LTD

Primary DI Number: 05056619801403
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 221947288 *Terms of Use

Device Description: Sterilisation Case - Inner Layer (2 of 2)

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?
13730	Device sterilization/disinfection container, reusable	A receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. 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: 1352e1e5-59bc-40a2-a6db-d909bf3c433b
Public Version Date: June 21, 2024
Public Version Number: 1
DI Record Publish Date: June 13, 2024