Carnegie Surgical LLC

Basic Information

• Brand Name: Carnegie Surgical LLC
• Primary DI: G141558294100
• Version / Model: 558-29410
• Catalog Number: 558-29410
• Company Name: Carnegie Surgical LLC
• Labeler DUNS: 017636482
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-26
• Public Version: 1
• Public Version Date: 2023-04-03
• Public Version Status: New
• Public Device Record Key: a417def9-9b1b-47fa-8c49-03d23d52b18e

Device Description

FOLEY Catheter tip punch, stainless steel, size 25 x 40 x 10 mm

Device Characteristics

• Single Use: No
• 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: 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
LRY	Punch, Surgical	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47100	Urethral drainage catheter punch	A hand-held manual instrument designed for cutting a small hole (e.g., 0.3 mm diameter) into the distal end of a closed Foley catheter (usually 14.0 French or larger) to form a "Council tip Foley catheter", allowing it to be placed over a guidewire or ureteral catheter. The punch is made of high-grade stainless steel and is typically used in a sterile environment to open the end of the Foley catheter before it is used. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G141558294100	HIBCC

Customer Contacts

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