Identity
- Trade Name
- PoleStar® FDA UDI
- Generic Name
- Extremity MRI system, permanent magnet FDA UDI
- Device Name
- FLEXCOIL 9733063 BAND D/E ADJUSTBLE 10PK FDA UDI
- Model / Reference
- 9733063 FDA UDI
- Description
- FLEXCOIL 9733063 BAND D/E ADJUSTBLE 10PK FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00613994209658 FDA UDI
- 510(k) Number
- K032541 FDA UDI
- FDA Product Code
- LNH 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Extremity MRI system, permanent magnet
PoleStar® by Medtronic Navigation, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Extremity MRI system, permanent magnet.
- Swoop Point-of-Care Magnetic Resonance Imaging Scanner — Hyperfine Operations, Inc. · Class II
- WristView — Aspect Imaging, Ltd. · Class II
- Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner — Hyperfine Operations, Inc. · Class II
- S-scan — Esaote · Class II
- PoleStar®, Trumpf JUPITER™ — MEDTRONIC NAVIGATION, INC. · Class II
Cleared under the same submission
K032541 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtronic Navigation, Inc.
Sources (1)
- FDA UDI 0f78051f-1b62-4586-abcb-565f867f78a9 35 fields · synced May 31, 2026