Alleset

Basic Information

• Brand Name: Alleset
• Primary DI: 16931918163192
• Version / Model: 30-01518-S
• Company Name: GRI Medical & Electronic Technology Co., Ltd.
• Labeler DUNS: 679894738
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2022-11-27
• Public Version: 1
• Public Version Date: 2022-12-05
• Public Version Status: New
• Public Device Record Key: 0e513a13-870b-4998-8c16-74f2749e9f45

Device Description

Needle Counter_Red_15-Count_Foam strips_Clear top_Sterile_100ea/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: MR Conditional
• 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
GAB	Needle, Suturing, Disposable	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61634	Sharp surgical instrument counting tray/pad, single-use	A device intended to be used in the operating room (OR) by staff to maintain the count of various sharp surgical instruments (e.g., needles, blades, scissors) to prevent instruments from being inadvertently left in a patient; it may in addition be used for temporary storage of instruments during surgery. The counter is usually flat when in use and employs magnetism, foam rubber, or some other mechanism to hold the counted objects in place. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	26931918163199	GS1		2	In Commercial Distribution
Primary	16931918163192	GS1
Unit of Use	06931918163195	GS1

Customer Contacts

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