Identity
- Trade Name
- Long Drill 4.0x80 FDA UDI
- Generic Name
- Stereotactic surgery system probe, reusable FDA UDI
- Model / Reference
- MAS2265-04S FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290115751826 FDA UDI
- 510(k) Number
- K203005 FDA UDI
- FDA Product Code
- OLO FDA UDILLZ FDA UDI
- GMDN Term
- Stereotactic surgery system probe, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI892.2050 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
Yes
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Stereotactic surgery system probe, reusable
Long Drill 4.0x80 by Mazor Robotics Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Stereotactic surgery system probe, reusable.
- ACUFEX — Smith & Nephew, Inc. · Class I
- ASTRA-OCT Spine System — SPINECRAFT LLC · Class II
- 7D Surgical Iliac Cannula, 150 mm — 7D Surgical ULC · Class II
- ASTRA Spine System — SPINECRAFT LLC · Class II
- ZAVATION PEDICLE PROBE — ZAVATION · Class I
- ASTRA Spine System — SPINECRAFT LLC · Class II
- Navigation — SPINEOLOGY INC. · Class II
- ACUFEX — Smith & Nephew, Inc. · Class I
Cleared under the same submission
K203005 also covers:
- 10.5 Arm Guide KIT — MAZOR ROBOTICS LTD
- 10.5 Arm Guide Screw Kit — MAZOR ROBOTICS LTD
- 360° Bridge — MAZOR ROBOTICS LTD
- 4.75 Arm Guide Screw Kit — MAZOR ROBOTICS LTD
- 5.5/6.0 Arm Guide Kit — MAZOR ROBOTICS LTD
- 5.5/6.0 Arm Guide Screw Kit — MAZOR ROBOTICS LTD
- Arm Guide — MAZOR ROBOTICS LTD
- Arm Guide — MAZOR ROBOTICS LTD
- Blunt — MAZOR ROBOTICS LTD
- Bone Mount Bridge — MAZOR ROBOTICS LTD
- Branch — MAZOR ROBOTICS LTD
- Bridge Adaptor — MAZOR ROBOTICS LTD
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
- Mazor Robotics Ltd
Sources (1)
- FDA UDI 8f2dd91b-dd79-411c-b4b9-c43eb3c11c7a 33 fields · synced May 30, 2026