FDA UDI In Commercial Distribution 🇺🇸 United States

G-22

DI: 04560141950795 · Model: AE83 · KONICA MINOLTA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
G-22
Primary DI
04560141950795
Version / Model
AE83
Company Name
KONICA MINOLTA, INC.
Labeler DUNS
692076161
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-06-14
Public Version
1
Public Version Date
2023-06-22
Public Version Status
New
Public Device Record Key
b0f27c3b-4143-4c92-bda0-9e7e05759b3a

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
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)

GMDN Terms

Code Name
36545 Basic power supply, reusable

Identifiers

Type ID
Primary 04560141950795

Premarket Submissions

Submission Number Supplement Number
K223267 000