FDA UDI Not in Commercial Distribution 🇺🇸 United States

Philips Medical Systems DMC

DI: 08057737120411 · Model: Juno DRF · VILLA SISTEMI MEDICALI SPA
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Philips Medical Systems DMC
Primary DI
08057737120411
Version / Model
Juno DRF
Company Name
VILLA SISTEMI MEDICALI SPA
Labeler DUNS
439173964
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-24
Public Version
5
Public Version Date
2019-08-05
Public Version Status
Update
Public Device Record Key
c804d27f-45ca-4ed4-99d7-3e20d51b186c
Distribution End Date
2019-07-31

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
KPW Device, Beam Limiting, X-Ray, Diagnostic
IXL Device, Spot-Film
KXJ Table, Radiologic

GMDN Terms

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

Identifiers

Type ID
Primary 08057737120411

Premarket Submissions

Submission Number Supplement Number
K050190 000