FDA UDI In Commercial Distribution 🇺🇸 United States

Dynamic DR Room

DI: 00817100020100 · Model: RF6000 · KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Dynamic DR Room
Primary DI
00817100020100
Version / Model
RF6000
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
40c014be-bb6b-4b27-9564-76580ecdf719

Device Description

Platinum Radiographic / Fluoroscopic system 90/90 DRF43 FL with generator and X-Ray tube.

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
No
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
JAA System, X-Ray, Fluoroscopic, Image-Intensified

GMDN Terms

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

Identifiers

Type ID
Primary 00817100020100

Customer Contacts