Identity
- Trade Name
- Temena FDA UDI
- Generic Name
- Intramuscular injection site nerve-locating/electromyography system FDA UDI
- Device Name
- Peripheral Nerve Block Stimulator FDA UDI
- Model / Reference
- 27050-01 FDA UDI
- Description
- Peripheral Nerve Block Stimulator FDA UDI
Identifiers
- Catalog Number
- 27050-01 FDA UDI
- Primary DI / UDI-DI
- 03700339716395 FDA UDI
- FDA Product Code
- BXN FDA UDI
- GMDN Term
- Intramuscular injection site nerve-locating/electromyography system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.2775 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
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intramuscular injection site nerve-locating/electromyography system
Temena by Te ME NA Sas — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intramuscular injection site nerve-locating/electromyography system.
- Vive — VIVE HEALTH LLC · Class II
- Myoguide System Model 8008 — Intronix Technologies Corp. · Class II
- Temena — Te ME NA Sas · 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
- Te ME NA Sas
Sources (1)
- FDA UDI 7c2dd147-85a4-4bd7-a4a5-43fb3de31986 34 fields · synced May 31, 2026