Identity
- Trade Name
- wrist pad FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- These accessory immobilization devices are intended for use in conjunction with a NeoCoil Flex Coil for patient comfort and stabilization. Please refer to the device labeling for intended use of your particular NeoCoil Flex Coil. FDA UDI
- Model / Reference
- 52 FDA UDI
- Description
- These accessory immobilization devices are intended for use in conjunction with a NeoCoil Flex Coil for patient comfort and stabilization. Please refer to the device labeling for intended use of your particular NeoCoil Flex Coil. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00856181003527 FDA UDI
- 510(k) Number
- K113474 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: MRI system coil, radio-frequency
wrist pad by Neocoil, Llc — 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
- 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
- Variety Positioning Aid Set Pediatrics — NORAS MRI products GmbH · Class II
Cleared under the same submission
K113474 also covers:
- 1.5T GEM Flex Interface, 8ch Combined, HD-Connector — NEOCOIL, LLC
- 11 x 6.5 x 1.5 pad — NEOCOIL, LLC
- 11 x 6.5 x 1.5 wedge pad — NEOCOIL, LLC
- 11 x 6.5 x 3 pad — NEOCOIL, LLC
- 14 x 4 x 2 wedge pad — NEOCOIL, LLC
- 5 x 3 x 1 pad — NEOCOIL, LLC
- 7.5 x 3.5 x 2 pad — NEOCOIL, LLC
- 8 x 3 x 0.5 pad — NEOCOIL, LLC
- Cable Take-up pad — NEOCOIL, LLC
- Flex Coils Pediatric Stabilizer — NEOCOIL, LLC
- GEM Flex Knee Stabilizer for Curved Tables — NEOCOIL, LLC
- GEM Flex Knee Stabilizer for Flat Tables — NEOCOIL, LLC
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
- Neocoil, Llc
Sources (1)
- FDA UDI bb73a0d4-2201-4ca7-b52e-9bb56b603069 34 fields · synced May 30, 2026