AccessGUDID - DEVICE: PHASOR (B7755800)

GUDID

Device Identifier (DI) Information

Brand Name: PHASOR
Version or Model: 5.80
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5.80
Company Name: PHASOR HEALTH LLC

Primary DI Number: B7755800
Issuing Agency: HIBCC
Commercial Distribution End Date: February 20, 2123
Device Count: 1
Labeler D-U-N-S® Number*: 111926675 *Terms of Use

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

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:	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?
46277	Automatic cranial perforator, single-use	A sterile, metallic rotary endpiece designed to cut a circular section, or sections, of the skull vault (calvarium) to provide access to the interior for diagnostic/therapeutic purposes or for the removal of a bone flap for brain surgery. It typically consists of two coaxial drill shafts (one rotating inside the other), a drive shank that enables connection to a powered (either electrical or pneumatic) handpiece, and a built-in clutch mechanism. The inner drill shaft extends slightly beyond the outer cutter in such a way that when the inner drill shafts penetrates the inner table of the skull the clutch mechanism disengages. 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 [?]
K161704	000

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: 27cf104b-946e-48d6-b73c-6ec9581abd4f
Public Version Date: February 28, 2023
Public Version Number: 1
DI Record Publish Date: February 20, 2023