Sterile Disposable Button Cannula, 45 mm length

Basic Information

• Brand Name: Sterile Disposable Button Cannula, 45 mm length
• Primary DI: 04260462742801
• Version / Model: KK45R50S
• Catalog Number: KK45R50S
• Company Name: Pemax Kunststoff GmbH
• Labeler DUNS: 341672714
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2024-06-05
• Public Version: 1
• Public Version Date: 2024-06-13
• Public Version Status: New
• Public Device Record Key: d0679f8d-37d2-49db-a7d5-90fec191b540

Device Description

Sterile Disposable Button Cannula, 45 mm length

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
GBX	Catheter, Irrigation	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62389	Wound irrigation cannula	A rigid or semi-rigid tube intended to be connected to a parent device (e.g., syringe) to channel irrigation fluids (e.g., saline solution) to a skin or surgical wound for washing and removing debris; it is not intended for aspiration of fluids. This is a single-use device intended to be used in a sterile condition.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04260462742818	GS1	Case	15	In Commercial Distribution
Primary	04260462742801	GS1
Unit of Use	04260462741408	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -10 – 35 Degrees Celsius