Identity
- Trade Name
- S-scan FDA UDI
- Generic Name
- Extremity MRI system, permanent magnet FDA UDI
- Model / Reference
- 9800020010 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08056304451095 FDA UDI
- FDA Product Code
- LNH FDA UDIMOS FDA UDI
- GMDN Term
- Extremity MRI system, permanent magnet FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
MR Safe FDA UDI
Category: Extremity MRI system, permanent magnet
S-scan by Esaote — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- PoleStar® — MEDTRONIC NAVIGATION, INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Esaote
Sources (1)
- FDA UDI 6d4e8e41-aa1e-4aee-b722-906c5263b9d0 32 fields · synced May 30, 2026