← Back to catalogue
Biopsy Grid Assembly, Pack, Breast Coil
FDA UDIEUDAMEDClass II (US FDA UDI)
by Neocoil, Llc
Identity
- Trade Name
- Biopsy Grid Assembly, Pack, Breast Coil FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Model / Reference
- 51 FDA UDI
Identifiers
- Catalog Number
- NC149444 FDA UDI
- Primary DI / UDI-DI
- 00850028932513 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
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
Yes
FDA UDI
Category: MRI system coil, radio-frequency
Biopsy Grid Assembly, Pack, Breast Coil by Neocoil, Llc — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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 (2)
- FDA UDI 1edafb74-b2b5-4be0-af45-4328bb4d9e6c 33 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026