AccessGUDID - DEVICE: PHASOR (B775GREDRI0)

GUDID

Device Identifier (DI) Information

Brand Name: PHASOR
Version or Model: GRE.DRI
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PHASOR HEALTH LLC

Primary DI Number: B775GREDRI0
Issuing Agency: HIBCC
Commercial Distribution End Date: November 23, 2125
Device Count: 1
Labeler D-U-N-S® Number*: 111926675 *Terms of Use

Device Description: Phasor GREEN Drill is a re-sterilizable drill driver (for use on one ore more patients, up to 10 total holes), with separately packaged single-use sterilized drill bit assembly -- for use on adult patients during neurosurgical procedures for drilling of cranial bone. (This item refers to the re-sterilizable drill driver.)

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
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

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K252060	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Hydrogen Peroxide

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: 54557019-533d-4978-aac1-6366fcd15a59
Public Version Date: December 02, 2025
Public Version Number: 1
DI Record Publish Date: November 24, 2025