FDA UDI In Commercial Distribution 🇺🇸 United States

Peri-Pro III Intraoral Film Processor

DI: D678940000 · Model: 94000 · AIR TECHNIQUES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

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Basic Information

Brand Name
Peri-Pro III Intraoral Film Processor
Primary DI
D678940000
Version / Model
94000
Company Name
AIR TECHNIQUES, INC.
Labeler DUNS
043835081
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-23
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
6ff1cdd6-09d5-4991-a265-9618be1ad4a3

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

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
Yes
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
IXW Processor, Radiographic-Film, Automatic

GMDN Terms

Code Name
15939 Dental automated x-ray film processor

Identifiers

Type ID
Primary D678940000
Package D67894000M1

Customer Contacts

Device Sizes

Type Value Unit Text
Weight 22 Pound
Depth 10 Inch
Width 25 Inch
Height 8.5 Inch

Storage Conditions

Type
Storage Environment Humidity
Temperature Range
0 – 95 Percent (%) Relative Humidity
Type
Storage Environment Temperature
Temperature Range
-10 – 60 Degrees Celsius