FDA UDI
In Commercial Distribution
🇺🇸 United States
PHASOR
DI: B775580K0
·
Model: 5.80K
·
PHASOR HEALTH LLC
Product Codes
1
GMDN Terms
3
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PHASOR
- Primary DI
- B775580K0
- Version / Model
- 5.80K
- Catalog Number
- 5.80K
- Company Name
- PHASOR HEALTH LLC
- Labeler DUNS
- 111926675
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-20
- Public Version
- 1
- Public Version Date
- 2023-02-28
- Public Version Status
- New
- Public Device Record Key
- 09496e58-2798-47e1-bb33-395ae0217f8a
- Distribution End Date
- 2123-02-20
Device Description
Phasor Drill 5.80-mm diameter, ~70-mm usable length with drill stop extension (tapered) + Kit (version A1) with Stapler
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | Neurology | 882.4310 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35884 | Skin stapler/staple, non-bioabsorbable | A hand-held manual, surgical instrument preloaded with non-bioabsorbable skin staples designed to apply the staples to approximate the free skin edges of an incision or wound. The staples (which may be clip-like) are made of metal [e.g., stainless steel or titanium (Ti)] and intended to be removed once the wound has sufficiently healed. This is a single-use device. | No | Active |
| 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 |
| 46277 | Automatic cranial perforator, single-use | A sterile, metallic rotary endpiece designed to cut a circular section, or sections, of the skull vault (calvarium) to provide access to the interior for diagnostic/therapeutic purposes or for the removal of a bone flap for brain surgery. It typically consists of two coaxial drill shafts (one rotating inside the other), a drive shank that enables connection to a powered (either electrical or pneumatic) handpiece, and a built-in clutch mechanism. The inner drill shaft extends slightly beyond the outer cutter in such a way that when the inner drill shafts penetrates the inner table of the skull the clutch mechanism disengages. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B775580K0 | HIBCC |
Customer Contacts
- Phone
- 8329821234
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K161704 | 000 |