AccessGUDID - DEVICE: SYSTEM, X-RAY, STATIONARY (08809246620032)

GUDID

Device Identifier (DI) Information

Brand Name: SYSTEM, X-RAY, STATIONARY
Version or Model: TITAN 11
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TITAN 11
Company Name: GEMSS MEDICAL SYSTEMS CO.,LTD.

Primary DI Number: 08809246620032
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 689163897 *Terms of Use

Device Description: TITAN 11 is a diagnostic DR System that contains high output capacity and high-resolution image processing system. During a surgery, the presence of lesions, size, and location can be recorded easily as Radiography images. The important images can be stored within the device so taking Radiography images is convenient.

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:	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?
17904	Computed radiography digital imaging scanner	A device/device assembly designed to be used with an analogue x-ray system to capture radiographic images and then generate digital x-ray images from them as part of a two-step process (computed radiography) for image viewing, storage, or hard-copy printing; it is not dedicated to dental use. It consists of an image reader/scanner and may also include an exposure unit with imaging receptor (e.g., a cassette containing a plate), or additional supportive hardware (e.g., a printer). The image is acquired on a photostimulable substance (e.g., a phosphor screen mounted on a cassette plate) and converted into an electrical analogue signal in a laser scanner.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPR	System, X-Ray, Stationary

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K133695	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
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 50 and 103 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ba5b5e31-e721-458c-a64e-f3e2fb537bc1
Public Version Date: July 25, 2024
Public Version Number: 7
DI Record Publish Date: September 24, 2016