AccessGUDID - DEVICE: DIRECTVIEW CR Cassette with PQ Screen (60889971640987)

GUDID

Device Identifier (DI) Information

Brand Name: DIRECTVIEW CR Cassette with PQ Screen
Version or Model: DIRECTVIEW CR Cassette with PQ Screen
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1640986
Company Name: CARESTREAM HEALTH, INC.

Primary DI Number: 60889971640987
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 793169512 *Terms of Use

Device Description: 35x35CM DV CR REPLACMT PLATE/PQ SCR

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?
44824	Digital imaging cassette/phosphor plate	A device that includes both a digital imaging cassette and a phosphor plate (also known as screen) intended to receive radiation by a diagnostic x-ray system, to record a patient radiation pattern during a non-dental procedure. The device is then transferred, with the cassette shielding the plate from environmental light, to a computed radiography (CR) scanner for insertion to produce the digital image of the patient. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IXA	Cassette, radiographic film

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K040378	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
Storage Environment Temperature: between 10 and 24 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a25a34a1-6fcd-434f-9d26-832213297edc
Public Version Date: June 19, 2024
Public Version Number: 5
DI Record Publish Date: September 16, 2016