AccessGUDID - DEVICE: Axis Spine Technologies ALIF System Instrument (05060771809870)

GUDID

Device Identifier (DI) Information

Brand Name: Axis Spine Technologies ALIF System Instrument
Version or Model: A6202450
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A6202450
Company Name: AXIS SPINE TECHNOLOGIES LTD

Primary DI Number: 05060771809870
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 221947288 *Terms of Use

Device Description: ALIF Slim Tamp

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?
32873	Surgical tamp, reusable	A hand-held, surgical instrument designed to be used to manually pack tissue or other material during a surgical intervention. It typically consists of a shaft that terminates in a blunt (flat or profiled) tip at the distal end and a handle at the proximal end. It is typically a one-piece instrument made of metal, however some types may employ a synthetic material for the handle (e.g., Tufnol). The surgeon may pack the material by applying hand pressure to the device or by tapping the proximal end with a hammer/mallet. 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: 0851ae55-94d0-4d4c-8897-2bf26580a834
Public Version Date: May 25, 2023
Public Version Number: 1
DI Record Publish Date: May 17, 2023