index Asurity

Basic Information

• Brand Name: index Asurity
• Primary DI: 16945630137638
• Version / Model: Index Asurity 4#
• Company Name: Sterilance Medical (Suzhou) Inc.
• Labeler DUNS: 554434897
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2025-08-25
• Public Version: 1
• Public Version Date: 2025-09-02
• Public Version Status: New
• Public Device Record Key: 865aca0b-2d7e-4b9f-b615-bb91294874af

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: 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization, Ultraviolet Light

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GDZ	Handle, Scalpel	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12235	Scalpel handle, reusable	A 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 reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	36945630137632	GS1		15	In Commercial Distribution
Primary	16945630137638	GS1
Unit of Use	06945630137631	GS1