Identity
- Trade Name
- PHASOR FDA UDI
- Generic Name
- Neurosurgical procedure kit, medicated FDA UDI
- Device Name
- Phasor Drill 6.35-mm diameter, ~70-mm usable length with drill stop extension (tapered) + Kit (version A1) with Stapler FDA UDI
- Model / Reference
- 6.35K FDA UDI
- Description
- Phasor Drill 6.35-mm diameter, ~70-mm usable length with drill stop extension (tapered) + Kit (version A1) with Stapler FDA UDI
Identifiers
- Catalog Number
- 6.35K FDA UDI
- Primary DI / UDI-DI
- B775635K0 FDA UDI
- 510(k) Number
- K161704 FDA UDI
- FDA Product Code
- HBE FDA UDI
- GMDN Term
- Neurosurgical procedure kit, medicated 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Neurosurgical procedure kit, medicatedSkin stapler/staple, non-bioabsorbableAutomatic cranial perforator, single-use
Phasor by Phasor Health, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Automatic cranial perforator, single-use.
- EasyDrill Cranial Perforator Ø9 x Ø6 x 3mm — Micromar Indústria e Comércio Ltda · Class II
- EasyDrill Cranial Perforator Ø9 x Ø6 x 3mm — Micromar Indústria e Comércio Ltda · Class II
- Evonos — Evonos GmbH & Co. KG · Class II
- Evonos — Evonos GmbH & Co. KG · Class II
- Zyphr — Stryker Corp. · Class II
- EasyDrill Cranial Perforator Ø14 x Ø11 x 1, 5mm — Micromar Indústria e Comércio Ltda · Class II
- ACRA-CUT — ACRA-CUT INC · Class II
- ACRA-CUT — 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 |
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Manufacturer
- Manufacturer
- Phasor Health, LLC
Sources (1)
- FDA UDI 202bbd5b-0f94-4b99-86b4-9388ab03ada3 37 fields · synced May 30, 2026