Snowden-Pencer

Basic Information

• Brand Name: Snowden-Pencer
• Primary DI: 10885403152290
• Version / Model: 88-2347
• Catalog Number: 88-2347
• Company Name: CAREFUSION 2200, INC
• Labeler DUNS: 832696038
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-07-13
• Public Version: 3
• Public Version Date: 2024-02-02
• Public Version Status: Update
• Public Device Record Key: bedbc64d-459e-4e06-8fc4-feaf8435b163

Device Description

Snowden-Pencer MAXWELL AREOLA MARKER 42MM, DIAMETER 42MM DIA

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
FZZ	MARKER, SKIN	General, Plastic Surgery	878.4660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62727	Skin marking guide, reusable	A device intended to be used as a guide to create an accurate mark on the skin surface with a drawing skin marker (e.g., a skin marking pen), or by itself after having been dipped in a marking agent (e.g., ink), typically to outline a surgical incision site or for dermatology applications. It is typically shaped specifically for its intended application. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10885403152290	GS1

Customer Contacts

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