MemoFix® Super Elastic Nitinol Staple System

Basic Information

• Brand Name: MemoFix® Super Elastic Nitinol Staple System
• Primary DI: 10381780246237
• Version / Model: MS-2920
• Catalog Number: MS-2920
• Company Name: Ascension Orthopedics, Inc.
• Labeler DUNS: 942377524
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-05
• Public Version: 4
• Public Version Date: 2023-01-25
• Public Version Status: Update
• Public Device Record Key: eea0d073-ee01-4dca-8482-9877be917bd4
• Distribution End Date: 2026-12-31

Device Description

Integra® MemoFix® Staple System The MemoFix tamp is used to push down the staple into the bone.

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
HXG	TAMP	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32873	Surgical tamp, reusable	A hand-held, surgical instrument designed to be used to manually pack tissue or other material during a surgical intervention. It typically consists of a shaft that terminates in a blunt (flat or profiled) tip at the distal end and a handle at the proximal end. It is typically a one-piece instrument made of metal, however some types may employ a synthetic material for the handle (e.g., Tufnol). The surgeon may pack the material by applying hand pressure to the device or by tapping the proximal end with a hammer/mallet. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M269MS29201	HIBCC
Primary	10381780246237	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			6.02 in L