SANDEL

Basic Information

• Brand Name: SANDEL
• Primary DI: 35414566830081
• Version / Model: 1011-NNS
• Catalog Number: 1011-NNS
• Company Name: Ansell Sandel Medical Solutions LLC
• Labeler DUNS: 107961166
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2022-03-25
• Public Version: 1
• Public Version Date: 2022-04-04
• Public Version Status: New
• Public Device Record Key: a221c193-f7e6-4336-a7fd-5cbac295a8a3

Device Description

SANDEL PETITE SKIN MARKER, BULK (NS)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation 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
61575	Skin marking pen, single-use	A dedicated pen intended to be used to delineate areas on the skin surface of a patient (e.g., to outline surgical incision sites, for dermatology applications) utilizing non-toxic ink. It is typically a felt-tip pen which may include a sterile disposable ruler. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00071483005073	GS1
Primary	35414566830081	GS1

Customer Contacts

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