N/A

Basic Information

• Brand Name: N/A
• Primary DI: 03596010548740
• Version / Model: 013526D
• Catalog Number: 013526D
• Company Name: Smith & Nephew, Inc.
• Labeler DUNS: 045483575
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-04-12
• Public Version: 5
• Public Version Date: 2023-09-07
• Public Version Status: Update
• Public Device Record Key: 476aa7c7-6513-46b1-84b8-144ee85d80d6
• Distribution End Date: 2022-03-17

Device Description

REFURB SIZING TUBE 10MM

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
HWT	TEMPLATE	Orthopedic	888.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44877	Ligament graft sizer, noninvasive	A surgical instrument that contains a series of holes of varying dimensions/sizes intended to be used in orthopaedic surgery [e.g., in anterior cruciate ligament (ACL) reconstruction surgery] to measure the size/diameter of a harvested graft to be implanted. It is used ex vivo [e.g., on the preparation table of the operating room (OR)] on a harvested graft. The measurement is subsequently used to determine the diameter of the tunnel drilled into the operative site (e.g., distal femur) for acceptance of the new graft. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03596010548740	GS1

Customer Contacts

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