SANDEL

Basic Information

• Brand Name: SANDEL
• Primary DI: 25414566810017
• Version / Model: 2200
• Catalog Number: 2200
• Company Name: Ansell Sandel Medical Solutions LLC
• Labeler DUNS: 107961166
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• 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: 1238e74d-49ac-4489-9518-0537c2361c07

Device Description

SANDEL SAFETY SCALPEL HANDLE, CAB, 2200

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: Yes
• Sterilization Prior Use: No

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
63270	Scalpel handle, single-use	A sterile device that is an interchangeable component of a scalpel and that functions as a handle designed to mount a compatible blade. This device with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting or dissecting tissue. The device is typically made of metal (e.g., stainless steel or brass). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	35414566810014	GS1	Case	4	In Commercial Distribution
Primary	25414566810017	GS1
Unit of Use	00071483005172	GS1

Customer Contacts

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