Identity
- Trade Name
- Phasor Drill FDA UDI
- Generic Name
- Craniotomy power tool system, battery-powered, single-use FDA UDI
- Device Name
- 2 Flute Drill Bit. FDA UDI
- Model / Reference
- 008-1047 FDA UDI
- Description
- 2 Flute Drill Bit. FDA UDI
Identifiers
- Catalog Number
- PH-270-70 FDA UDI
- Primary DI / UDI-DI
- M710PH270700 FDA UDI
- FDA Product Code
- HBE FDA UDIKIJ FDA UDIGFG 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 UDI878.4820 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
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 2.7 Millimeter 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 630d565e-254d-4779-a191-d7546b2503d3 38 fields · synced May 30, 2026