NA

Basic Information

• Brand Name: NA
• Primary DI: 04042409196409
• Version / Model: IS 1702-08
• Company Name: aap Implantate AG
• Labeler DUNS: 328420633
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-28
• Public Version: 1
• Public Version Date: 2018-04-02
• Public Version Status: New
• Public Device Record Key: 08f9103f-5f61-44bd-8e27-4c1e0bc22f01

Device Description

Cleaning wire ø0.8, CS 2.0/2.7

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: Yes
• 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
GFC	DRIVER, SURGICAL, PIN	General, Plastic Surgery	878.4820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44802	Orthopaedic instrument cleaning tool	A hand-held manual device designed to clean the residual tissue or debris that remains embedded on or in an orthopaedic surgical instrument (e.g., reamers, bone taps) following use. The device can be in the form of wire or a strip of metal. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04042409196409	GS1