AccessGUDID - DEVICE: XPRESS: FV-53 PEDO FILM (H665186361)

GUDID

Device Identifier (DI) Information

Brand Name: XPRESS: FV-53 PEDO FILM
Version or Model: 18636
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 18636
Company Name: Flow X Ray Corporation

Primary DI Number: H665186361
Issuing Agency: HIBCC
Commercial Distribution End Date: June 22, 2023
Device Count: 100
Labeler D-U-N-S® Number*: 010016319 *Terms of Use

Device Description: F SPEED CHILD SIZE 0 FILM, TWO FILMS PER PACKET, 100 FILMS PER BOX.

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?
40978	Dental x-ray film, non-screen	A non-screen x-ray film specifically sized and designed for use with dental x-ray systems. It 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
Handling Environment Temperature: less than 21 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dc34500d-a3a2-40c6-af89-066774c8cd2c
Public Version Date: June 28, 2023
Public Version Number: 5
DI Record Publish Date: September 06, 2016