AccessGUDID - DEVICE: PHASOR (B775PH63570DTPHKAS0)

GUDID

Device Identifier (DI) Information

Brand Name: PHASOR
Version or Model: PH-635-70-DT + PH-K-AS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PH-635-70-DT + PH-K-AS
Company Name: PHASOR HEALTH LLC

Primary DI Number: B775PH63570DTPHKAS0
Issuing Agency: HIBCC
Commercial Distribution End Date: November 28, 2120
Device Count: 1
Labeler D-U-N-S® Number*: 111926675 *Terms of Use

Device Description: Phasor Drill 6.35-mm diameter, ~70-mm length, with Drill Stop Extension (Tapered) + Kit (version A) with stapler

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Obsolete	false
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: aa95c697-3297-4efa-9b36-48373a4aad49
Public Version Date: December 07, 2020
Public Version Number: 1
DI Record Publish Date: November 28, 2020