AccessGUDID - DEVICE: RTM 78 HS (08059307490481)

GUDID

Device Identifier (DI) Information

Brand Name: RTM 78 HS
Version or Model: 0.6/1.2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: I.A.E. INDUSTRIA APPLICAZIONI ELETTRONICHE SPA

Primary DI Number: 08059307490481
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 430263475 *Terms of Use

Device Description: Rotating anode X-ray tube for radiography systems

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?
35618	X-ray tube housing assembly, diagnostic	A metallic (e.g., steel, aluminium alloy) case that houses an x-ray tube to provide appropriate limits for x-ray leakage and adequate insulation to avoid electric risks during a diagnostic x-ray procedure. It includes sheet lead surrounds at appropriate locations to shield unwanted x-ray radiation and collimators near the aperture; it is usually filled with oil to prevent electrical arcs from the high-voltage components of the x-ray tube. The housing also includes attachment points, cooling means, high-voltage cables, and supports for the tube and cable receptacles. It may be an independent unit mounted in a tube support, or under a fluoroscopic table as a component of a radiographic system.	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: 6937b998-b3bf-4e8f-9bc7-39ce8320a58b
Public Version Date: September 02, 2020
Public Version Number: 1
DI Record Publish Date: August 25, 2020