AccessGUDID - DEVICE: Quala (D02318635QU1)

GUDID

Device Identifier (DI) Information

Brand Name: Quala
Version or Model: 18635-QU
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 18635-QU
Company Name: NATIONAL DISTRIBUTION & CONTRACTING, INC.

Primary DI Number: D02318635QU1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 009831413 *Terms of Use

Device Description: Quala Intraoral X-ray Film QF54 Child F Speed

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
Storage Environment Temperature: less than 23 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d54728b0-3693-426a-abe4-9698bf9ed092
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: April 11, 2017