Bending cylinder for Pectus bars, 13.7 mm supplement for 020-00021

Basic Information

• Brand Name: Bending cylinder for Pectus bars, 13.7 mm supplement for 020-00021
• Primary DI: 04260029580167
• Version / Model: 020-00029
• Catalog Number: 020-00029
• Company Name: MedXpert GmbH
• Labeler DUNS: 331019344
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-09
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: a2ac3749-8894-4e71-8883-79bf1e5c98f3

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: Yes
• 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
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58343	Rib/rib cage internal fixation/bracing system bending pliers	A hand-held manual surgical instrument designed to be used with a rib/rib cage internal fixation/bracing system for bending the rib grip or bracing bar implants to a specific shape, e.g., to modify the angulation of a rib clip. The instrument is typically made of high-grade steel and consists of two arms that form a handle proximally and extend distally through a pivot to form jaws that bend the metal rib grips or bracing bars allowing the surgeon to customize their shape. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260029580167	GS1

Customer Contacts

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