AccessGUDID - DEVICE: DIRECTVIEW CR Mammography Cassette with EHR-M Screen (40889971290386)

GUDID

Device Identifier (DI) Information

Brand Name: DIRECTVIEW CR Mammography Cassette with EHR-M Screen
Version or Model: DIRECTVIEW CR Mammography Cassette with EHR-M Screen
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1290386
Company Name: CARESTREAM HEALTH, INC.

Primary DI Number: 40889971290386
Issuing Agency: GS1
Commercial Distribution End Date: May 11, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 793169512 *Terms of Use

Device Description: DIRECTVW CR Mammo Cass EHR-M2 Scrn 18x24

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?
44825	Digital imaging cassette/storage phosphor screen, mammographic	A combination device for mammography applications that consists of a cassette used to hold and shield an attached storage phosphor screen from exposure to room light during transport and insertion into a diagnostic mammography x-ray system, and a computed radiography scanner. The photostimulatable storage phosphor screen is exposed to radiation by the mammography x-ray system to record a patient radiation pattern. The cassette is then loaded into a laser scanner capable of reading the latent image formed on the storage phosphor screen to produce a digital image.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
MUE	Full field digital,system,x-ray,mammographic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P080018	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: f295b42c-cc8d-436a-b365-bd252d04651f
Public Version Date: May 14, 2021
Public Version Number: 4
DI Record Publish Date: September 16, 2016