AccessGUDID - DEVICE: Universal Chuck Set for the IntelliSense Drill System (B666MCG80020)

GUDID

Device Identifier (DI) Information

Brand Name: Universal Chuck Set for the IntelliSense Drill System
Version or Model: 1.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MCG8002
Company Name: MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC

Primary DI Number: B666MCG80020
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078568266 *Terms of Use

Device Description: Universal Pin Driver for IntelliSense Drill

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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):	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?
43660	Pin-driving power tool attachment	A device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a wire driving/insertion function when an appropriate orthopaedic pin is inserted (e.g., K-Wire). It may include integral design features, e.g., have an angled head or have an extended body length to better suit a particular activity. The device may be of the micro or macro design. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 74423a6a-6f85-4792-ba30-fad21c5a6813
Public Version Date: September 18, 2023
Public Version Number: 2
DI Record Publish Date: December 05, 2022