AccessGUDID - DEVICE: DRX Plus 4343 DETECTOR (60889971746146)

GUDID

Device Identifier (DI) Information

Brand Name: DRX Plus 4343 DETECTOR
Version or Model: DRX Plus 4343 DETECTOR
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1746148
Company Name: CARESTREAM HEALTH, INC.

Primary DI Number: 60889971746146
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 793169512 *Terms of Use

Device Description: DRX Plus 4343 portable grid holder

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?
40915	Stationary x-ray grid	A component of an x-ray system used in diagnostic x-ray imaging applications, e.g., planar x-ray imaging or mammography. It typically consists of a housing containing lead foil strips separated by x-ray transparent spacers. These spacers or "interspaces" are filled with aluminium (Al) or another x-ray transparent (radiolucent) organic compound. Radiographic grids are placed between the x-ray target (patient) and the x-ray film and are used to absorb scatter radiation, and improve radiographic image contrast. It typically comes in two patterns, linear and crossed. Most are focused to a line in space called a convergent line, but can be used over a variable range called the focal distance.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IXJ	Grid, radiographic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K090318	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: 7d813f5c-5590-42d7-a4e6-a1541c2808af
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 16, 2016