AccessGUDID - DEVICE: PHASOR (B775PH45070DTPHKA1S0)

GUDID

Device Identifier (DI) Information

Brand Name: PHASOR
Version or Model: PH-450-70-DT+PH-K-A1S
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PHASOR HEALTH LLC

Primary DI Number: B775PH45070DTPHKA1S0
Issuing Agency: HIBCC
Commercial Distribution End Date: October 30, 2122
Device Count: 1
Labeler D-U-N-S® Number*: 111926675 *Terms of Use

Device Description: Phasor Drill, 4.50-mm diameter, with Drill Stop Extension (Tapered) with Kit (version A1), 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?
46272	Cranial trephine, single-use	A neurosurgical blade used to cut/remove circular sections of the skull vault (calvarium) to provide access to the interior, e.g., for the insertion of a catheter or a neuroscope for diagnosis, or treatments such as, to alleviate intracranial pressure (ICP), obtain cerebrospinal fluid samples, inject radiopaque dyes. It may be used to make several holes for the removal of a bone flap. It is typically a hollow cylinder with a circular, saw-like serrated working edge and a centre drill for guidance. It is an exchangeable device, typically made of high-grade stainless steel, that is attached to a manually rotated handle or to a powered rotary surgical handpiece. This is a single-use device.	Active	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: ed90fba2-6cf8-4825-ad77-61f1b1d8510d
Public Version Date: November 07, 2022
Public Version Number: 1
DI Record Publish Date: October 30, 2022