MEDLINEUNITE

Basic Information

• Brand Name: MEDLINEUNITE
• Primary DI: 10080196016747
• Version / Model: MSN10011
• Catalog Number: MSN10011
• Company Name: MEDLINE INDUSTRIES, INC.
• Labeler DUNS: 025460908
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-23
• Public Version: 1
• Public Version Date: 2020-10-01
• Public Version Status: New
• Public Device Record Key: ca05cf7f-5ca8-4ecb-8f29-76a3efecb2a7

Device Description

DRILL BIT, CANN, AO/QC, HOOK SCRW, 3.0MM

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HWC	Screw, fixation, bone	Orthopedic	888.3040	2
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61768	Catheter-exchange guidewire holder	A sterile hand-held device intended for use during guidewire-assisted intravascular interventional procedures [e.g., percutaneous transluminal coronary angioplasty (PTCA)] to facilitate the exchange of one catheter for another (e.g., coronary angioplasty balloon catheter) while maintaining the position of the guidewire. It consists of a clip for mechanical attachment to part of the catheterization device set, and a magnetic channel through which the catheter/guidewire is passed to enable removal of the catheter while the metal guidewire is magnetically held in place. This is a single-use device.	No	Active
16462	Surgical countersink, reusable	A rotary surgical instrument designed to enlarge the diameter of the proximal portion of a hole drilled in bone. It is a shaft of metal with a cutting head, available in various configurations, that is rotated at low speeds typically by a drilling system. The device is typically used to recess the head of a screw/bolt within bone (enable it to lie flush with or below the bone surface) or to help accommodate the implantation of a device in bone. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10080196016747	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]