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
EGY Processor, Radiographic-Film, Automatic, Dental

GMDN Terms

Code Name
15939 Dental automated x-ray film processor

Identifiers

Type ID
Primary B580EGY0