FDA UDI
In Commercial Distribution
🇺🇸 United States
AFP 810
DI: B580EGY0
·
Model: AFP 810 Basic
·
AFP MANUFACTURING, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AFP 810
- Primary DI
- B580EGY0
- Version / Model
- AFP 810 Basic
- Catalog Number
- 2001
- Company Name
- AFP MANUFACTURING, INC.
- Labeler DUNS
- 080326963
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-06-19
- Public Version
- 1
- Public Version Date
- 2019-06-27
- Public Version Status
- New
- Public Device Record Key
- 3126e00d-0516-4ee0-94e1-c1edff746f3a
Device Description
x-ray film processor, dental
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| EGY | Processor, Radiographic-Film, Automatic, Dental | 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 | B580EGY0 | HIBCC |