AccessGUDID - DEVICE: Oncology EDR2 Film (40889971161761)

GUDID

Device Identifier (DI) Information

Brand Name: Oncology EDR2 Film
Version or Model: Oncology EDR2 Film
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1161769
Company Name: CARESTREAM HEALTH, INC.

Primary DI Number: 40889971161761
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 793169512 *Terms of Use

Device Description: ONCO EDR2 FILM 35X43-14X17 RDYPK 50SH

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:	Yes
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?
40980	Medical x-ray film, non-screen	A non-screen x-ray film specifically designed for use in medical imaging applications. Non-screen x-ray film is designed for direct exposure to x-rays and is relatively insensitive to the visible light emitted from screens. It is prepared as an emulsion of light and x-ray sensitive granules on one (single-emulsion film) or both (double-emulsion film) sides of a transparent film base made of cellulose acetate, polyester resin or other appropriate material.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IWZ	Film, radiographic

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
Storage Environment Humidity: between 30 and 50 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 24 Degrees Celsius
Storage Environment Temperature: between 10 and 24 Degrees Celsius
Handling Environment Humidity: between 30 and 50 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 63de261b-0e40-45cb-aaa9-b2f315ad6c34
Public Version Date: May 13, 2019
Public Version Number: 3
DI Record Publish Date: September 16, 2016