FDA UDI
In Commercial Distribution
🇺🇸 United States
PHASOR
DI: B775PH63570DTPHKAS0
·
Model: PH-635-70-DT + PH-K-AS
·
PHASOR HEALTH LLC
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PHASOR
- Primary DI
- B775PH63570DTPHKAS0
- Version / Model
- PH-635-70-DT + PH-K-AS
- Catalog Number
- PH-635-70-DT + PH-K-AS
- Company Name
- PHASOR HEALTH LLC
- Labeler DUNS
- 111926675
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-11-28
- Public Version
- 1
- Public Version Date
- 2020-12-07
- Public Version Status
- New
- Public Device Record Key
- aa95c697-3297-4efa-9b36-48373a4aad49
- Distribution End Date
- 2120-11-28
Device Description
Phasor Drill 6.35-mm diameter, ~70-mm length, with Drill Stop Extension (Tapered) + Kit (version A) 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 |
|---|---|---|---|---|
| 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 |
| 46275 | Craniotomy power tool system, battery-powered, single-use | A dedicated battery-powered assembly of devices 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)]; it may also be used for the removal of a bone flap for brain surgery. It typically consists of a handpiece containing a motor (engine), a battery-pack, an attachment with a clutch system that disengages the cutting tool when the inner table has been penetrated preventing injury to the brain, and an exchangeable rotating cutting tool (e.g., a cranial drill bit, bur, trephine or perforator). This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B775PH63570DTPHKAS0 | HIBCC |