NA

Basic Information

• Brand Name: NA
• Primary DI: 00885554018554
• Version / Model: 72203144
• Catalog Number: 72203144
• Company Name: Smith & Nephew, Inc.
• Labeler DUNS: 045483575
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-08-29
• Public Version: 4
• Public Version Date: 2023-09-07
• Public Version Status: Update
• Public Device Record Key: d0ad0757-9c66-4092-93a9-4c4130f1e115

Device Description

MTO BONE TUNNEL PLUGS 11-12 X 4.75

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
NBH	ACCESSORIES,ARTHROSCOPIC	Orthopedic	888.1100	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45190	Bone tunnel plug, non-cannulated	A device typically intended to prevent irrigation fluid from exiting the knee joint via the tibial tunnel [a channel drilled through the knee joint during anterior cruciate ligament (ACL) repair] to maintain visualization of the joint during arthroscopy. The device typically has a rounded cap at the proximal end and tapers distally; it is not cannulated. It is inserted manually into the tunnel, is available in a variety of diameters, and is made of hard plastic. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20885554018558	GS1	BX	3	In Commercial Distribution
Primary	00885554018554	GS1

Customer Contacts

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