PENDING

Basic Information

• Brand Name: PENDING
• Primary DI: 10080196012619
• Version / Model: MPN10035
• Catalog Number: MPN10035
• Company Name: MEDLINE INDUSTRIES, INC.
• Labeler DUNS: 025460908
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-21
• Public Version: 1
• Public Version Date: 2020-08-31
• Public Version Status: New
• Public Device Record Key: f5692a9f-9893-408b-803c-da0f6c73f632

Device Description

DRILL BIT, SOLID CORE, 3.5MM

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HTO	REAMER	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62058	Cannulated surgical drill guiding pin	A sterile metal shaft (pin) designed to fit into the hollow centre of a cannulated surgical drill bit to provide a guide for drilling during a surgical procedure. The pin is bored into hard tissue (e.g., bone), typically by means of a surgical power tool handpiece, and the cannulated drill bit is subsequently fed over it during the drilling procedure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10080196012619	GS1

Customer Contacts

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