Identity
- Trade Name
- Omnia FDA UDI
- Generic Name
- Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer FDA UDI
- Device Name
- Patient Remote 3000 Kit FDA UDI
- Model / Reference
- PTRC3000 FDA UDI
- Description
- Patient Remote 3000 Kit FDA UDI
Identifiers
- Catalog Number
- PTRC3000 FDA UDI
- Primary DI / UDI-DI
- 00813426020596 FDA UDI
- PMA Number
- P130022 FDA UDI
- FDA Product Code
- LGW FDA UDI
- GMDN Term
- Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer FDA UDI
Classification
- Device Class
- Class III 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: Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer
Omnia by Nevro Corporation — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer.
- Bioventus Clinician Kit — BIOVENTUS LLC · Class II
- ReActiv8 Programming Wand — MAINSTAY MEDICAL LIMITED · Class III
- BIOTRONIK — BIOTRONIK SE & Co. KG · Class III
- Altius Programmer Wand — Neuros Medical, Inc. · Class III
- Omnia — Nevro Corporation · Class III
Cleared under the same submission
P130022 also covers:
- Nevro — Nevro Corporation
- Nevro — Nevro Corporation
- Nevro — Nevro Corporation
- Nevro® — Nevro Corporation
- Nevro® — Nevro Corporation
- Nevro® — Nevro Corporation
- Nevro® — Nevro Corporation
- Nevro® — Nevro Corporation
- Nevro® — Nevro Corporation
- Nevro® — Nevro Corporation
- Nevro® — Nevro Corporation
- Nevro® — Nevro Corporation
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 III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nevro Corporation
Sources (1)
- FDA UDI 9378c8f0-4aea-44b3-8641-62974d0ba126 35 fields · synced May 30, 2026