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
- 008-1043 FDA UDI
- Description
- 2 Flute Drill Bit. FDA UDI
Identifiers
- Catalog Number
- PH-580-70 FDA UDI
- Primary DI / UDI-DI
- M710PH580700 FDA UDI
- FDA Product Code
- GFG FDA UDIKIJ FDA UDIHBE FDA UDI
- GMDN Term
- Craniotomy power tool system, battery-powered, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 FDA UDI882.4310 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
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 5.8 Millimeter FDA UDI
Phasor Drill by Biotex, Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Biotex, Inc.
Sources (1)
- FDA UDI 3dbfc205-03b2-45ad-8aa6-5a730478b7c0 38 fields · synced Jun 6, 2026