AccessGUDID - DEVICE: NA (08806088088266)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: GM60A-40S
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Samsung Electronics Co., Ltd.

Primary DI Number: 08806088088266
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 687967554 *Terms of Use

Device Description: The GM60A-40S Digital Mobile X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.

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?
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
IZL	System, X-Ray, Mobile
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K150097	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: ddcd82cf-dff2-44fa-b4f8-13627c242912
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016