NA

Basic Information

• Brand Name: NA
• Primary DI: 10886982006707
• Version / Model: SD397.730
• Catalog Number: SD397730
• Company Name: Synthes GmbH
• Labeler DUNS: 486711679
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-31
• Public Version: 3
• Public Version Date: 2022-04-28
• Public Version Status: Update
• Public Device Record Key: e98347d7-08ba-47cb-85fb-0041e8d7bbb2

Device Description

Ø8.0MM STRAIGHT BALL SPIKE

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
HWA	IMPACTOR	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47874	Orthopaedic ball spike	A hand-held manual surgical instrument used in the surgical wound to reposition a bone fragment during a surgical intervention. It is typically a robust instrument designed with a handle at the proximal end and a long, sturdy, shaft that terminates in a singularly pointed ball head at the distal end. It is typically made of high-grade stainless steel and/or synthetic material and is used by the surgeon to reposition and hold bone fragments. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	H679SD3977300	HIBCC
Primary	10886982006707	GS1

Customer Contacts

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