FDA UDI Not in Commercial Distribution 🇺🇸 United States

THALES 3D MR SCANNER

DI: 04260590370754 · Model: Carriage System · L A P GMBH LASER APPLIKATIONEN
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
THALES 3D MR SCANNER
Primary DI
04260590370754
Version / Model
Carriage System
Catalog Number
0016165-0001
Company Name
L A P GMBH LASER APPLIKATIONEN
Labeler DUNS
313586582
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-12-14
Public Version
2
Public Version Date
2021-09-17
Public Version Status
Update
Public Device Record Key
7635c7d7-04f4-44c6-9a88-2f589926692b
Distribution End Date
2021-09-17

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
MR Conditional
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
IYE Accelerator, Linear, Medical

GMDN Terms

Code Name
40631 Multi-modality therapeutic radiation phantom, test object

Identifiers

Type ID
Primary 04260590370754

Premarket Submissions

Submission Number Supplement Number
K200907 000