FDA UDI
In Commercial Distribution
🇺🇸 United States
PHASOR
DI: B7752IN126LK0
·
Model: 2-IN-1-26LK
·
PHASOR HEALTH LLC
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PHASOR
- Primary DI
- B7752IN126LK0
- Version / Model
- 2-IN-1-26LK
- Company Name
- PHASOR HEALTH LLC
- Labeler DUNS
- 111926675
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-24
- Public Version
- 2
- Public Version Date
- 2026-03-30
- Public Version Status
- Update
- Public Device Record Key
- ada88a89-a878-471b-8f83-f30143b6f661
- Distribution End Date
- 2125-11-23
Device Description
The Phasor Drill is a sterile, single-use, disposable device intended for use on adult patients during neurosurgical procedures for drilling of cranial and orthopedic bone, with interchangeable quick-connect, 2 bits (diameters 2.70-mm, 6.35-mm) with Kit. The Phasor LEGACY drill is a sterile, single-use, disposable device intended for use on adult patients during neurosurgical procedures for drilling of cranial bone.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OJG | Neurological Tray | Neurology | 882.4525 | 1 |
| HBG | Drills, Burrs, Trephines & Accessories (Manual) | Neurology | 882.4300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44064 | Neurosurgical procedure kit, medicated | A collection of various sterile neurosurgical instruments, dressings, pharmaceuticals, and the necessary materials used to perform a neurosurgical procedure. This is a single-use device. | No | Active |
| 46281 | Manual cranial rotary handpiece, single-use | A manually-powered, hand-held, surgical device intended to be used to remove circular sections of the skull vault (calvarium) to provide access to the interior for diagnosis (e.g., the insertion of a neuroscope), or treatments [e.g., to alleviate intracranial pressure (ICP)], or for the removal of a bone flap for brain surgery. It is typically a drill brace or a housing containing bevelled and/or straight teethed gears rotated via a side handle, and a Jacobs chuck or gripping collet to attach an exchangeable rotating endpiece (e.g., a cranial drill, bur, trephine or perforator). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B7752IN126LK0 | HIBCC |