AccessGUDID - DEVICE: Peri-Pro III Intraoral Film Processor (D678940000)

GUDID

Device Identifier (DI) Information

Brand Name: Peri-Pro III Intraoral Film Processor
Version or Model: 94000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AIR TECHNIQUES, INC.

Primary DI Number: D678940000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 043835081 *Terms of Use

Device Description: Peri-Pro III Intraoral Film Processor is a roller-less transport system that guides up to eight films at once through the developing process. The films are processed, dried with heated air, and deposited into the film receptacle dry-to dry and ready to read. Includes: 1 case chemistry, film carriers: 3 Pedo film carriers, 2 adult anterior film carriers, 2 bite-wing film carriers, 1 occlusal film carrier, 1 water bottle.

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:	Yes
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?
15939	Dental automated x-ray film processor	A mains electricity (AC-powered) automated dental x-ray film processor designed to be used in the dental practise for the rapid processing of films. This x-ray film processing system will automatically develop, fix, wash, and dry dental x-ray film. It is typically of floor or desktop design.	Active	false

FDA Product Code

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Product Code	Product Code Name
IXW	Processor, Radiographic-Film, Automatic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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 Humidity: between 0 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 22 Pound
Depth: 10 Inch
Width: 25 Inch
Height: 8.5 Inch

Device Record Status

Public Device Record Key: 6ff1cdd6-09d5-4991-a265-9618be1ad4a3
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016