Alleset

Basic Information

• Brand Name: Alleset
• Primary DI: 16931918191850
• Version / Model: 25-2016
• Company Name: GRI Medical & Electronic Technology Co., Ltd.
• Labeler DUNS: 679894738
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 125
• Record Status: Published
• Publish Date: 2022-11-14
• Public Version: 1
• Public Version Date: 2022-11-22
• Public Version Status: New
• Public Device Record Key: 50200ae8-c78d-4cd8-9791-30a8e8c5d343

Device Description

Sponge Wire Cleaning_SM Wing_size 3.5"x3.4"x1"_500ea/cs

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	880.6025	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15281	Surgical scrub sponge	A hand-held device that includes an absorbent, porous material designed to wash the skin of the arms, hands, and the fingernails in preparation for a medical/surgical procedure. It is typically multilayered and impregnated with an antimicrobial solution. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	26931918191857	GS1		4	In Commercial Distribution
Primary	16931918191850	GS1
Unit of Use	06931918191853	GS1

Customer Contacts

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