PHASOR PH-580-70-D

GUDID B775PH58070D0

Phasor Drill 5.80-mm diameter, ~70-mm length, with Depth Stop Extension (DSE)

PHASOR HEALTH LLC

Cranial trephine, single-use Cranial trephine, single-use Cranial trephine, single-use Cranial trephine, single-use Cranial trephine, single-use Cranial trephine, single-use Cranial trephine, single-use Cranial trephine, single-use Cranial trephine, single-use Cranial trephine, single-use Cranial trephine, single-use Cranial trephine, single-use Cranial trephine, single-use Cranial trephine, single-use Cranial trephine, single-use Cranial trephine, single-use

• Primary Device ID: B775PH58070D0
• NIH Device Record Key: 3bffafe1-3df1-457f-acc6-bc4ff12f17e0
• Commercial Distribution Discontinuation: 2120-05-21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PHASOR
• Version Model Number: PH-580-70-D
• Catalog Number: PH-580-70-D
• Company DUNS: 111926675
• Company Name: PHASOR HEALTH LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B775PH58070D0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161704

FDA Product Code

• HBE: Drills, Burrs, Trephines & Accessories (Simple, Powered)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-03-07
• Device Publish Date: 2020-05-21

On-Brand Devices [PHASOR]

• B775PH63570PHKAS0: Phasor Drill 6.35-mm diameter, ~70-mm length + Kit (version A) with Stapler
• B775PH63570PHKA1S0: Phasor Drill 6.35-mm diameter, ~70-mm length with conventional drill stop + Kit (version A1) wit
• B775PH63570DTPHKAS0: Phasor Drill 6.35-mm diameter, ~70-mm length, with Drill Stop Extension (Tapered) + Kit (version
• B775PH63570DTPHKA1S0: Phasor Drill 6.35-mm diameter, ~70-mm usable length with drill stop extension (tapered) + Kit (v
• B775PH63570DPHKAS0: Phasor Drill 6.35-mm diameter,~70-mm length + Kit (version A) with stapler
• B775PH63570DPHKA1S0: Phasor Drill 6.35-mm diameter, ~70-mm length with drill stop extension (untapered) + Kit (versio
• B775PH63570DPHKA0: Phasor Drill 6.35-mm diameter, ~70-mm length with drill stop extension (untapered) + Kit (versio
• B775PH53070DPHKA0: Phasor Drill 5.30-mm diameter, ~70-mm length with drill stop extension (untapered) + Kit (versio
• B775PH45070DPHKA10: Phasor Drill 4.50-mm diameter, ~70-mm length with Drill Stop Extension (untapered) + Kit (versio
• B775PH45070DPHKA0: Phasor Drill 4.50-mm diameter, ~70-mm length with drill stop extension (untapered) + Kit (versio
• B775PH27070SPHKA10: Phasor Drill 2.70-mm diameter, ~70-mm length with Optional Secondary Drill Stop and Kit (version
• B775PH27070SPHKA0: Phasor Drill 2.70-mm diameter, ~70-mm length with Optional Secondary Drill Stop + Kit (Version A
• B775PH27070PHKA0: Phasor Drill 2.70-mm diameter, ~70-mm length with conventional drill stop + Kit (version A)
• B775PH24070S0: Phasor Drill 2.40-mm diameter, ~70-mm length with optional secondary drill stop
• B775PH635DT0: Phasor Drill, 6.35-mm diameter, with Drill Stop Extension (tapered)
• B775PH53070DTPHKA1S0: Phasor Drill, 5.30-mm diameter, with Drill stop extension, Tapered, plus Kit (version A1) with s
• B775PH53070DT0: Phasor Drill, 5.30-mm diameter, with Drill Stop Extension, Tapered
• B775PH45070DTPHKA10: Phasor Drill, 4.50-mm diameter, with Drill Stop Extension (Tapered) with Kit (version A1)
• B775PH45070DT0: Phasor Drill, 4.50-mm diameter, with Drill Stop Extension, Tapered
• B775PH27070S0: Phasor Drill, 2.70-mm diameter, short, with Optional Secondary Drill Stop
• B775PH63570PHK20: Phasor Drill 6.35-mm diameter, ~70-mm length + Kit (version 2)
• B775PH63570PHK10: Phasor Drill 6.35-mm diameter, ~70-mm length + Kit (version 1)
• B775PH63570D0: Phasor Drill 6.35-mm diameter, ~70-mm usable length, with Drill Stop Extension (DSE)
• B775PH635700: Phasor Drill 6.35-mm diameter, ~70-mm length
• B775PH58070D0: Phasor Drill 5.80-mm diameter, ~70-mm length, with Depth Stop Extension (DSE)
• B775PH580700: Phasor Drill 5.80-mm diameter, ~70-mm length
• B775PH53070DPHK20: Phasor Drill 5.30-mm diameter, ~70-mm length + Kit (version 2)
• B775PH45070PHK10: Phasor Drill 4.50-mm diameter, ~70-mm length + Kit (version 1)
• B775PH45070DPHK10: Phasor Drill 4.50-mm diameter, ~70-mm length, with Depth Stop Extension (DSE) and Kit (version 1
• B775PH3202100: Phasor Drill 3.20-mm diameter, length ~210-mm
• B775PH27070PHK20: Phasor Drill 2.70-mm diameter with Optional Secondary Drill Stop (OSDS), ~70-mm length + Kit
• B775PH27070PHK10: Phasor Drill 2.70-mm diameter, ~70-mm length + Kit (version 1)
• B775PH270700: Phasor Drill 2.70-mm diameter, ~70-mm length
• B775PH2702100: Phasor Drill 2.70-mm diameter, ~210-mm length
• B775PH240700: Phasor Drill 2.40-mm diameter, ~70-mm length
• B775PH240210PHK20: Phasor Drill 2.40-mm, ~210-mm length + Kit (version 2)
• B775PH2402100: Phasor Drill 2.40-mm diameter, ~210-mm length
• B775PH45070DTPHKA1S0: Phasor Drill, 4.50-mm diameter, with Drill Stop Extension (Tapered) with Kit (version A1), Stapl
• B775450K0: Phasor Drill, 4.50-mm diameter, with Drill Stop Extension (Tapered) with Kit (version A1), Stapl
• B775635K0: Phasor Drill 6.35-mm diameter, ~70-mm usable length with drill stop extension (tapered) + Kit (v
• B7756350: Phasor Drill, 6.35-mm diameter, with Drill Stop Extension (tapered)
• B775580K0: Phasor Drill 5.80-mm diameter, ~70-mm usable length with drill stop extension (tapered) + Kit (v
• B7755800: Phasor Drill 5.80-mm diameter, ~70-mm length, with Depth Stop Extension (DSE) tapered
• B775530K0: Phasor Drill, 5.30-mm diameter, with Drill stop extension, Tapered, plus Kit (version A1) with s
• B7755300: Phasor Drill, 5.30-mm diameter, with Drill Stop Extension, Tapered
• B7754500: Phasor Drill, 4.50-mm diameter, with Drill Stop Extension, Tapered
• B775320L0: Phasor Drill 3.20-mm diameter, length ~210-mm
• B775270S0: Phasor Drill, 2.70-mm diameter, short, with Optional Secondary Drill Stop
• B775270L0: Phasor Drill 2.70-mm diameter, ~210-mm length
• B775270K0: Phasor Drill 2.70-mm diameter, ~70-mm length with Optional Secondary Drill Stop and Kit