Identity
- Trade Name
- Preamp Box Foam Sleeve 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
- 63 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
- 00856181003633 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
Preamp Box Foam Sleeve by Neocoil, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as MRI system coil, radio-frequency.
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- NORAS OR HEADCOIL Bottom Array Siemens 3T Refurbished — NORAS MRI products GmbH · Class II
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- 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 2ef8ab10-a27c-441b-8572-4a64e2620e5c 34 fields · synced May 30, 2026