FDA UDI In Commercial Distribution 🇺🇸 United States

LUMINOS Lotus Max

DI: 04056869269931 · Model: 11574100 · Siemens Healthcare GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
LUMINOS Lotus Max
Primary DI
04056869269931
Version / Model
11574100
Company Name
Siemens Healthcare GmbH
Labeler DUNS
313217003
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-11-01
Public Version
2
Public Version Date
2021-11-18
Public Version Status
Update
Public Device Record Key
8907eed4-5da1-4c41-bfe9-3a019871f984

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
Yes
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
OWB Interventional fluoroscopic x-ray system

GMDN Terms

Code Name
37679 Stationary general-purpose fluoroscopic x-ray system, digital

Identifiers

Type ID
Primary 04056869269931

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
K173639 000