4FUSION

Basic Information

• Brand Name: 4FUSION
• Primary DI: 07613252257943
• Version / Model: AGR104R
• Catalog Number: AGR104R
• Company Name: Stryker Trauma SA
• Labeler DUNS: 481999654
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-24
• Public Version: 2
• Public Version Date: 2023-08-14
• Public Version Status: Update
• Public Device Record Key: e16bcbe0-7770-4baa-a376-74d7cbcab6ca

Device Description

Cylindrical Graft Ejector

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
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44853	Orthopaedic bone staple, adjustable	A non-bioabsorbable, adjustable, L-shaped metallic implant intended to be used during reconstructive joint alignment or replacement typically to reattach bone fragments in high tibial osteotomy to correct the line of the knee joint. The device typically functions on a ratchet principle that compresses the bone ends into position. Disposable devices associated with implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613252257943	GS1