REUNITE SCREW SYSTEM

Basic Information

• Brand Name: REUNITE SCREW SYSTEM
• Primary DI: 00880304419339
• Version / Model: 348213
• Catalog Number: 348213
• Company Name: Biomet Orthopedics, LLC
• Labeler DUNS: 129278169
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-24
• Public Version: 4
• Public Version Date: 2023-09-18
• Public Version Status: Update
• Public Device Record Key: 2d9e1f03-d070-4172-8d60-cfc1d37fef81

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: MR Safe
• 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
HTY	PIN, FIXATION, SMOOTH	Orthopedic	888.3040	2
MAI	FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE	Orthopedic	888.3030	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	00880304419339	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K990291	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			2.4 MM 40 MM