AccessGUDID - DEVICE: AMRAD Medical (08055186670440)

GUDID

Device Identifier (DI) Information

Brand Name: AMRAD Medical
Version or Model: Agility
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 95 02 000
Company Name: A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL

Primary DI Number: 08055186670440
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 440069847 *Terms of Use

Device Description: This is a mobile X-ray device with a Flat Panel detector used for radiological guidance and visualization during diagnostic, interventional and surgical procedures. In particular, the device is to be applied during orthopedic, neuro, abdominal, vascular, thoracic and cardiac procedures. It can be used on all patients except pediatric patients within the limit of the device.

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?
37646	Mobile general-purpose fluoroscopic x-ray system, digital	A mobile (within an imaging facility) general-purpose diagnostic fluoroscopic x-ray system that uses a C-arm and digital techniques for image capture, display and manipulation and is designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging capabilities. It includes spot-film capabilities in addition to the fluoroscopic features and is intended to optimize the capability of users to visually and quantitatively evaluate the anatomy and physiological function of various targeted body areas in real-time. It is frequently used in conjunction with an ingested or injected x-ray contrast medium. Images can be both real-time and delayed formats.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OWB	Interventional Fluoroscopic X-Ray System
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K211777	000

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: d8e9b418-7100-4561-8d42-627dc52fe974
Public Version Date: April 04, 2022
Public Version Number: 1
DI Record Publish Date: March 25, 2022