AccessGUDID - DEVICE: CARESTREAM DR Long Length Imaging Stand (60889976554081)

GUDID

Device Identifier (DI) Information

Brand Name: CARESTREAM DR Long Length Imaging Stand
Version or Model: CARESTREAM DR Long Length Imaging Stand
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6554083
Company Name: CARESTREAM HEALTH, INC.

Primary DI Number: 60889976554081
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 793169512 *Terms of Use

Device Description: CARESTREAM DR LLI STAND

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?
40654	Basic diagnostic x-ray system table, non-powered	A non-powered table that is a component of a basic diagnostic x-ray system designed to position and support a patient during a variety of routine/planar or speciality diagnostic procedures requiring the use of a diagnostic x-ray system; it is not a planar tomography nor computed tomography (CT) table. It can be a stationary or mobile unit and is made of radiolucent materials with low x-ray attenuation coefficients. It is not intended for use during interventional radiology/surgery.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KXJ	Table, radiologic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: ea2022f4-09ae-4999-a817-ed691470a235
Public Version Date: March 12, 2019
Public Version Number: 5
DI Record Publish Date: September 16, 2016