Anzen Safety Scalpel

Basic Information

• Brand Name: Anzen Safety Scalpel
• Primary DI: 18886354702451
• Version / Model: AZ10
• Company Name: MEDIPURPOSE PTE. LTD.
• Labeler DUNS: 628380248
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-02
• Public Version: 6
• Public Version Date: 2021-11-15
• Public Version Status: Update
• Public Device Record Key: dcd49e4d-dd19-4b32-a93c-2fe48d360ae0

Device Description

Anzen Safety Scalpel Cartridge, #10 Blade, Blue

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: No
• 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
GES	Blade, Scalpel	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37445	Manual scalpel blade, single-use	An interchangeable device designed to mount a compatible handle and function as the cutting edge of a scalpel. It is made of high-grade stainless steel alloy and is used as a surgical instrument to cut and dissect tissues. Safety mechanisms (e.g., a retractable protective guard made of plastic) may be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	58886354702459	GS1	Case	6	In Commercial Distribution
Package	48886354702452	GS1	Carton	3	In Commercial Distribution
Package	38886354702455	GS1	Box	50	In Commercial Distribution
Primary	18886354702451	GS1

Customer Contacts

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