Identity
- Trade Name
- Altius Cuff Medium FDA UDI
- Generic Name
- Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection FDA UDI
- Model / Reference
- FG-600-002 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810118490088 FDA UDI
- PMA Number
- P230020 FDA UDI
- FDA Product Code
- SAZ FDA UDI
- GMDN Term
- Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Altius Cuff Medium by Neuros Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
P230020 also covers:
- Altius Battery Charger — Neuros Medical, Inc.
- Altius Cuff Large — Neuros Medical, Inc.
- Altius Cuff Small — Neuros Medical, Inc.
- Altius IPG — Neuros Medical, Inc.
- Altius IPG Accessory Kit — Neuros Medical, Inc.
- Altius Patient Controller — Neuros Medical, Inc.
- Altius Programmer Wand — Neuros Medical, Inc.
- Altius Programming Application PC — Neuros Medical, Inc.
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 |
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Manufacturer
- Manufacturer
- Neuros Medical, Inc.
Sources (1)
- FDA UDI 826243e7-b2c4-447f-a28b-04a8a09932e2 33 fields · synced Jun 8, 2026