Identity
- Trade Name
- Magec External Remote Controller FDA UDI
- Generic Name
- Distraction implant adjustment remote control FDA UDI
- Device Name
- MAGEC ERC 2 FDA UDI
- Model / Reference
- ERC 2 FDA UDI
- Description
- MAGEC ERC 2 FDA UDI
Identifiers
- Catalog Number
- ERC 2 FDA UDI
- Primary DI / UDI-DI
- 00887517730657 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Distraction implant adjustment remote control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Distraction implant adjustment remote control
Magec External Remote Controller by NuVasive Specialized Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Distraction implant adjustment remote control.
- Magec External Remote Controller — NuVasive Specialized Orthopedics, Inc. · Class II
- Magec External Remote Controller — NuVasive Specialized Orthopedics, Inc. · Class II
- Precice External Remote Controller — NuVasive Specialized Orthopedics, Inc. · Class II
- Precice External Remote Controller — NuVasive Specialized Orthopedics, Inc. · Class II
- Precice External Remote Controller — NuVasive Specialized Orthopedics, Inc. · Class II
- Precice External Remote Controller — NuVasive Specialized Orthopedics, Inc. · Class II
- PRECICE® Intramedullary Limb Lengthening System — NuVasive Specialized Orthopedics, Inc. · Class II
- Precice External Remote Controller — NuVasive Specialized Orthopedics, Inc. · Class II
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
- NuVasive Specialized Orthopedics, Inc.
Sources (1)
- FDA UDI ed11f933-882b-4b14-9084-ffd6d41773a2 35 fields · synced May 31, 2026