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 | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IXW | Processor, Radiographic-Film, Automatic | Radiology | 892.1900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D678940000 | HIBCC | ||||
| Package | D67894000M1 | HIBCC | box | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-800-247-8324
- [email protected]
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