AccessGUDID - DEVICE: Amadeo M-DR mini (04250802902903)

GUDID

Device Identifier (DI) Information

Brand Name: Amadeo M-DR mini
Version or Model: Amadeo M-DR mini with Varex flat panel detector
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: AM1722
Company Name: Oehm und Rehbein GmbH

Primary DI Number: 04250802902903
Issuing Agency: GS1
Commercial Distribution End Date: December 13, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 344349290 *Terms of Use

Device Description: The portable and fully digital X-ray system Amadeo M-DR mini is for use for first aid services, intensive care units, emergency departments, as well as ships and mobile hospitals (e.g. container solutions) in inaccessible areas, in laboratories and scientific stations in remote parts of the world. The Amadeo M-DR mini is used for wireless digital X-ray imaging.

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:	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?
37647	Mobile basic diagnostic x-ray system, digital	An assembly of devices that comprise a digital general-purpose mobile diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation and the mobile design allows it to operate on mains or battery power and to be driven or pushed by an operator to various locations within a building or facility. It is commonly used for bedside imaging and for interventional and intraoperative imaging. It consists of basic modular configurations that can be upgraded. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

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
Weight: 79 Kilogram

Device Record Status

Public Device Record Key: 299b2a17-f01c-4051-a4bb-0aec8ba194d5
Public Version Date: December 14, 2023
Public Version Number: 2
DI Record Publish Date: December 05, 2018