Arthrex®

Basic Information

• Brand Name: Arthrex®
• Primary DI: 00888867031142
• Version / Model: AR-4005B-12
• Catalog Number: AR-4005B-12
• Company Name: ARTHREX, INC.
• Labeler DUNS: 131747628
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-15
• Public Version: 24
• Public Version Date: 2024-01-25
• Public Version Status: Update
• Public Device Record Key: a167a371-49e6-471f-a432-096c556d05d3

Device Description

ARTHREX MENISCAL DART, 12MM (5-BOX)

Device Characteristics

• Single Use: Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MAI	FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE	Orthopedic	888.3030	2
HTY	PIN, FIXATION, SMOOTH	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45037	Orthopaedic bone pin, bioabsorbable	A device in the form of a small diameter rod intended to be used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis, in the presence of additional immobilization. The rod may be smooth or partially threaded. The device is made of a material that is chemically degraded and typically absorbed by natural body processes (e.g., degradable polymers such as polydioxanone or polyglycolide). This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00888867031142	GS1
Secondary	M150AR4005B122	HIBCC
Package	10888867031149	GS1	Box	5	In Commercial Distribution

Customer Contacts

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