Identity
- Trade Name
- PHASOR FDA UDI
- Generic Name
- Cranial trephine, single-use FDA UDI
- Device Name
- Phasor Drill 6.35-mm diameter, ~70-mm length FDA UDI
- Model / Reference
- PH-635-70 FDA UDI
- Description
- Phasor Drill 6.35-mm diameter, ~70-mm length FDA UDI
Identifiers
- Catalog Number
- PH-635-70 FDA UDI
- Primary DI / UDI-DI
- B775PH635700 FDA UDI
- 510(k) Number
- K161704 FDA UDI
- FDA Product Code
- HBE FDA UDI
- GMDN Term
- Cranial trephine, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4310 FDA UDI
- Commercial Distribution
- 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
Category: Cranial trephine, single-use
Phasor by Phasor Health, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cranial trephine, single-use.
- Wire Pass Drill — ACRA-CUT INC · Class II
- Disposable Cranial Perforator — ACRA-CUT INC · Class II
- Disposable Cranial Perforator — ACRA-CUT INC · Class II
- Disposable Cranial Perforator — ACRA-CUT INC · Class II
- Wire Pass Drill — ACRA-CUT INC · Class II
- Disposable Cranial Perforator — ACRA-CUT INC · Class II
- Cranial Blade Disposable low speed — ACRA-CUT INC · Class II
- Disposable Cranial Perforator — ACRA-CUT INC · Class II
Cleared under the same submission
K161704 also covers:
- PHASOR — Phasor Health, LLC
- PHASOR — Phasor Health, LLC
- PHASOR — Phasor Health, LLC
- PHASOR — Phasor Health, LLC
- PHASOR — Phasor Health, LLC
- PHASOR — Phasor Health, LLC
- PHASOR — Phasor Health, LLC
- PHASOR — Phasor Health, LLC
- PHASOR — Phasor Health, LLC
- PHASOR — Phasor Health, LLC
- PHASOR — Phasor Health, LLC
- PHASOR — Phasor Health, LLC
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
- Phasor Health, LLC
Sources (1)
- FDA UDI 0a738a21-e920-453e-bc2b-0313ab13e1a5 36 fields · synced Jun 8, 2026