FDA UDI In Commercial Distribution 🇺🇸 United States

2020 Imaging Podiatry System

DI: 00817100020131 · Model: XR400i · KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
2020 Imaging Podiatry System
Primary DI
00817100020131
Version / Model
XR400i
Catalog Number
BD715
Company Name
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
Labeler DUNS
080269345
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-24
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
587cd75d-8af8-4e98-949e-546635cc39ec

Device Description

20/20 BiDirectional PDR X-ray Machine.

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
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
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
KPR System, X-Ray, Stationary

GMDN Terms

Code Name
37645 Stationary basic diagnostic x-ray system, digital

Identifiers

Type ID
Primary 00817100020131

Customer Contacts