Identity
- Trade Name
- Precice External Remote Controller FDA UDI
- Generic Name
- Distraction implant adjustment remote control FDA UDI
- Device Name
- PRECICE ERC 3P Shipping Pkg AU FDA UDI
- Model / Reference
- ERC 3P FDA UDI
- Description
- PRECICE ERC 3P Shipping Pkg AU FDA UDI
Identifiers
- Catalog Number
- EAD-P3-014 FDA UDI
- Primary DI / UDI-DI
- 00887517945327 FDA UDI
- 510(k) Number
- K170169 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
Precice External Remote Controller by NuVasive Specialized Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K170169 also covers:
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 |
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Manufacturer
- Manufacturer
- NuVasive Specialized Orthopedics, Inc.
Sources (1)
- FDA UDI bcbef5fb-ae2d-4737-99c1-25c077b688ca 36 fields · synced Jun 8, 2026