Identity
- Trade Name
- Optistar EUDAMEDLF FDA UDI
- Generic Name
- MRI contrast medium injection system, line-powered, stationary FDA UDI
- Device Name
- Optistar Elite MR Contrast Delivery System, Mobile Mount EUDAMEDFDA UDI
- Model / Reference
- 814002 EUDAMEDFDA UDI
- Description
- OptiStar Elite MR Contrast Delivery System, Mobile Mount FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10746190002642 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10746190002642 EUDAMED
- 510(k) Number
- K073592 FDA UDI
- FDA Product Code
- DXT FDA UDI
- EMDN Code
- Z11059001 MAGNETIC RESONANCE INJECTORS EUDAMED
- GMDN Term
- MRI contrast medium injection system, line-powered, stationary FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1650 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Optistar by Liebel-Flarsheim Company, LLC — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-10746190002642 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Liebel-Flarsheim Company, LLC
- EUDAMED SRN
- US-MF-000002605
- Authorised Representative
- Guerbet FR-AR-000000812
Sources (2)
- EUDAMED b65edb7b-9053-4b60-9cc6-099c2b6a1cfa 61 fields · synced Oct 6, 2026
- FDA UDI 86a9f3e2-938f-40db-8a92-148f7f05dc4f 34 fields · synced May 22, 2026