NA

Basic Information

• Brand Name: NA
• Primary DI: 10886982274236
• Version / Model: 03.404.000S
• Catalog Number: 03404000S
• Company Name: Synthes GmbH
• Labeler DUNS: 486711679
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-22
• Public Version: 3
• Public Version Date: 2023-01-16
• Public Version Status: Update
• Public Device Record Key: a9df1e5e-1ce1-448c-ae32-129af7f3b17d

Device Description

RIA 2 BONE HARVESTING KIT 520MM STERILE

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
HRX	Arthroscope	Orthopedic	888.1100	2
HTO	REAMER	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47951	Surgical power tool drive-shaft seal	A small sterile device designed as an external seal that is placed on the drive shaft of a rotary cutting tool (e.g., an orthopaedic reamer) that is attached to and driven by a surgical power tool in order to prevent the backflow of fluid (i.e., blood and rinsing fluid) penetrating the drive mechanisms of the power tool. It is made of synthetic material (e.g., silicone) and is available in a variety of shapes and sizes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10886982274236	GS1

Customer Contacts

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