Identity
- Trade Name
- AXiiiS Stereotactic Miniframe FDA UDI
- Generic Name
- Neurological stereotactic surgery system FDA UDI
- Device Name
- AXiiiS Trajectory Guide FDA UDI
- Model / Reference
- 20503 FDA UDI
- Description
- AXiiiS Trajectory Guide FDA UDI
Identifiers
- Catalog Number
- AX-300-01 FDA UDI
- Primary DI / UDI-DI
- 00816589020182 FDA UDI
- FDA Product Code
- HAW FDA UDI
- GMDN Term
- Neurological stereotactic surgery system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
AXiiiS Stereotactic Miniframe by Monteris Medical Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Monteris Medical Corp
Sources (1)
- FDA UDI a9b4a2bc-e0ae-428d-bb5a-5d689aac970e 36 fields · synced May 30, 2026