Alleset

Basic Information

• Brand Name: Alleset
• Primary DI: 16931918139807
• Version / Model: Model 30-1000
• Company Name: GRI Medical & Electronic Technology Co., Ltd.
• Labeler DUNS: 679894738
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 120
• Record Status: Published
• Publish Date: 2021-02-27
• Public Version: 1
• Public Version Date: 2021-03-08
• Public Version Status: New
• Public Device Record Key: 0600e1da-d288-4170-aaf0-fcc8acdc5f6f

Device Description

Tray _Sharps Transfer_Yellow_N/S_120ea/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: 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: 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
HXK	HOLDER, NEEDLE; ORTHOPEDIC	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61665	Surgical instrument containment holder, single-use, non-sterile	A non-sterile device intended to be used in the operating room (OR) by staff to safely contain/support a delicate or sharp hand-held, manual, surgical instrument(s) [e.g., needle, scalpel, scissors] to avoid damage to the instrument during surgery and/or to enable easy transfer/handling of the instrument at reduced risk of injury. It is available in various forms (e.g., rack, rest, puncture cushion, pocket, magnetic mat), and may be attached to a surgical drape; it is not a numbered tray and is not intended for counting of sharps. This is a single-use device intended to be sterilized prior to use.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	06931918139800	GS1
Primary	16931918139807	GS1

Customer Contacts

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