AccessGUDID - DEVICE: Amirix Imaging (00860013147662)

GUDID

Device Identifier (DI) Information

Brand Name: Amirix Imaging
Version or Model: LM33-T Diagnostic X-Ray Tube
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LM33-T
Company Name: Amirix Imaging LLC

Primary DI Number: 00860013147662
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119313747 *Terms of Use

Device Description: Diagnostic Mammography X-Ray Tube 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:	No
Prescription Use (Rx):	No
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?
16604	X-ray system tube	A replaceable component of a medical or dental diagnostic, or therapeutic x-ray system consisting of a tube (a glass envelope enclosing a filament, anode, cathode under vacuum, and an interface for an electrical connection) designed to convert an input of electrical energy into an output of x-ray energy. It is the x-ray system component that provides a supply of electrons which are free to move, a means of getting the electrons to travel at high-speed, and providing a force which will cause them to suddenly change direction which results in x-ray production. Included are designs referred to as cold-cathode gas discharge tubes, fixed anode tubes, rotating anode tubes, quick change tubes.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITY	Assembly, Tube Housing, X-Ray, Diagnostic

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: No

Sterilization Method [?]
No Sterilization Methods Found

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: 70bdbc9f-c6f8-4472-af27-343d8b957504
Public Version Date: November 26, 2024
Public Version Number: 1
DI Record Publish Date: November 18, 2024