Identity
- Trade Name
- DPA HAND/WRIST COIL FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- Coil for C-scan FDA UDI
- Model / Reference
- 9101643000 FDA UDI
- Description
- Coil for C-scan FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08056304453204 FDA UDI
- 510(k) Number
- K040877 FDA UDI
- FDA Product Code
- MOS FDA UDI
- GMDN Term
- MRI system coil, radio-frequency 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
Category: MRI system coil, radio-frequency
Dpa Hand/Wrist Coil by Esaote — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as MRI system coil, radio-frequency.
- Dunlee Sentinelle — Philips Medical Systems Nederland B.V. · Class II
- All-Purpose Arch — NORAS MRI products GmbH · Class II
- LEYLA Retractor Socket — NORAS MRI products GmbH · Class II
- 16Ch Flex SPEEDER Pad Kit — NEOCOIL, LLC · Class II
- All-Purpose Arch Adapter — NORAS MRI products GmbH · Class II
- Operator's Manual Flexibility Siemens — NORAS MRI products GmbH · Class II
- NORAS OR HEADCOIL Bottom Array Siemens 3T Refurbished — NORAS MRI products GmbH · Class II
- ScanMed Long Bone (L) Coil — SCANMED, LLC · Class II
Cleared under the same submission
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
- Esaote
Sources (1)
- FDA UDI f03f3871-777b-444d-ba75-cf85907fa72c 34 fields · synced May 30, 2026