AccessGUDID - DEVICE: Xstrahl 150 X-Ray System Floor (05060494200022)

GUDID

Device Identifier (DI) Information

Brand Name: Xstrahl 150 X-Ray System Floor
Version or Model: Xstrahl 150 X-Ray System Floor
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: XSTRAHL LIMITED

Primary DI Number: 05060494200022
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 491314738 *Terms of Use

Device Description: Xstrahl 150 X-Ray System Floor

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:	Yes
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?
59233	Stationary orthovoltage therapeutic x-ray system	An assembly of devices designed to produce low-energy x-rays used for therapeutic purposes, primarily in the treatment of skin cancer (e.g., basal cell or squamous cell carcinoma) or other skin conditions (e.g., psoriasis, keloid). The radiation source typically uses a tube voltage of between approximately 100 kV and 500 kV and will be used in conjunction with a variety of topical applicators. The main system is ceiling- or wall-mounted (fixed) in a radiotherapy suite or other clinical setting.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JAD	System, Therapeutic, X-Ray

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: 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: b0361a9a-3511-4ba8-904a-42ab6cff744e
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: January 27, 2017