Duns Number:043835081
Device Description: Peri-Pro III Intraoral Film Processor is a roller-less transport system that guides up to 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-wingfilm carriers, 1 occlusal film carrier, 1 water bottle.
Catalog Number
-
Brand Name
Peri-Pro III Intraoral Film Processor
Version/Model Number
94000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IXW
Product Code Name
Processor, Radiographic-Film, Automatic
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
Package DI Number
D67894000M1
Quantity per Package
1
Contains DI Package
D678940000
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |