Identity
- Trade Name
- Quattrode® FDA UDI
- Generic Name
- Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection FDA UDI
- Device Name
- Lead Wide Spaced, 110 cm FDA UDI
- Model / Reference
- 3161 FDA UDI
- Description
- Lead Wide Spaced, 110 cm FDA UDI
Identifiers
- Catalog Number
- 3161 FDA UDI
- Primary DI / UDI-DI
- 05414734401647 FDA UDI
- 510(k) Number
- K072462 FDA UDI
- FDA Product Code
- GZF FDA UDIGZB FDA UDI
- GMDN Term
- Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5870 FDA UDI882.5880 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 110 Centimeter FDA UDI
Quattrode® by Advanced Neuromodulation Systems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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
- Advanced Neuromodulation Systems
Sources (1)
- FDA UDI 3ea88727-893d-4847-aa2e-7686ea9de4ba 39 fields · synced May 30, 2026