SANDEL

Basic Information

• Brand Name: SANDEL
• Primary DI: 25414566810048
• Version / Model: 2210-N
• Catalog Number: 2210-N
• 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: 2022-03-28
• Public Version: 1
• Public Version Date: 2022-04-05
• Public Version Status: New
• Public Device Record Key: 3cf0ff9d-3fd3-45f1-ade5-d4d315722d37

Device Description

WEIGHTED SAFETY SCALPEL, #10 BLADE

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
GDX	Scalpel, One-Piece	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47569	Scalpel, single-use	A hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high-grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	35414566810045	GS1	Case	8	In Commercial Distribution
Primary	25414566810048	GS1
Unit of Use	00071483005226	GS1

Customer Contacts

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