AccessGUDID - DEVICE: Precision Cut EBT3 GafChromic(TM) Film (00860011127406)

GUDID

Device Identifier (DI) Information

Brand Name: Precision Cut EBT3 GafChromic(TM) Film
Version or Model: 158200
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 158200
Company Name: Computerized Imaging Reference Systems, Inc.

Primary DI Number: 00860011127406
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 108245655 *Terms of Use

Device Description: Precision Cut EBT3 GafChromic(TM) Film

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?
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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 69b2124b-50ba-4535-a043-b9862674fac8
Public Version Date: February 26, 2024
Public Version Number: 2
DI Record Publish Date: November 09, 2023