Identity
- Trade Name
- Myoject FDA UDI
- Generic Name
- Electromyographic needle electrode, single-use FDA UDI
- Device Name
- ALLERGAN USA BOTOX NEEDLE(box) FDA UDI
- Model / Reference
- 94514 FDA UDI
- Description
- ALLERGAN USA BOTOX NEEDLE(box) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00382830041195 FDA UDI
- FDA Product Code
- IKT FDA UDI
- GMDN Term
- Electromyographic needle electrode, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.1385 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electromyographic needle electrode, single-use
Myoject by Natus Manufacturing Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electromyographic needle electrode, single-use.
- The Electrode Store — IMPULSE MEDICAL TECHNOLOGIES, INC. · Class II
- Bio Protech — BIO PROTECH USA, INC. · Class II
- MediMax Tech — MEDIMAX TECH INC. · Class II
- Dragonfly® — NEUROVISION MEDICAL PRODUCTS, INC. · Class II
- Cobra® — NEUROVISION MEDICAL PRODUCTS, INC. · Class II
- Neuroline InojectNeurology Needle Electrodes — Ambu A/S · Class II
- NATUS NEUROLOGY — Natus Neurology Incorporated · Class II
- BIONEN — BIONEN SAS DI BARBARA NENCIONI & C. · 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
- Natus Manufacturing Limited
Sources (1)
- FDA UDI f0cc2c6b-0f10-475f-a58a-dc70f5d54628 33 fields · synced Jun 1, 2026