Identity
- Trade Name
- Phasor Drill FDA UDI
- Generic Name
- Craniotomy power tool system, battery-powered, single-use FDA UDI
- Model / Reference
- 1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M710008102804 FDA UDI
- FDA Product Code
- HBE FDA UDI
- GMDN Term
- Craniotomy power tool system, battery-powered, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4310 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Radiation Sterilization FDA UDI
MR Unsafe FDA UDI
Phasor Drill by Biotex, Inc. — 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
- Biotex, Inc.
Sources (1)
- FDA UDI a5d14be6-3ccb-4011-965d-92dac828c101 34 fields · synced May 30, 2026