Sizer Set - for Use with Osteochondral Allograft, PRE-CUT CORE

Basic Information

• Brand Name: Sizer Set - for Use with Osteochondral Allograft, PRE-CUT CORE
• Primary DI: 00860010346938
• Version / Model: PKG-90-AOI-000002
• Company Name: Swami Medical, LLC
• Labeler DUNS: 119319166
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-22
• Public Version: 1
• Public Version Date: 2024-08-30
• Public Version Status: New
• Public Device Record Key: 1208ed40-3b0b-48b2-997f-8506db1dad6a

Device Description

OCA Single-Use Sizer Set

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• 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
QBO	Instruments Designed For Press-Fit Osteochondral Implants	Orthopedic	888.4505	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56640	Orthopaedic implant-instrument extension adaptor, single-use	A sterile connecting device designed to join an orthopaedic implant to a surgical instrument, or a surgical instrument to another instrument, typically to create an extension for removal of the implant (e.g., during a percutaneous interspinous distraction procedure for the removal of a distraction sleeve), or to connect two devices with incompatible interfaces. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of sizes and lengths. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860010346938	GS1