Arthrex®

Basic Information

• Brand Name: Arthrex®
• Primary DI: 00888867001985
• Version / Model: ABS-10052
• Catalog Number: ABS-10052
• Company Name: ARTHREX, INC.
• Labeler DUNS: 131747628
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-15
• Public Version: 5
• Public Version Date: 2020-01-28
• Public Version Status: Update
• Public Device Record Key: 92b8eef6-46f4-43f5-a41c-6f7b344afde0
• Distribution End Date: 2020-01-27

Device Description

VISCOUS SPRAY II

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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
KYZ	SYRINGE, IRRIGATING (NON DENTAL)	General Hospital	880.6960	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35390	Irrigation syringe	A general-purpose device used primarily for the flushing of body orifices with an irrigating solution. It may be designed with (e.g., a rigid plastic barrel with a fitted rubber bulb at one end and a nozzle at the other). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00888867001985	GS1
Secondary	M150ABS100521	HIBCC
Package	10888867001982	GS1	Box	5	Not in Commercial Distribution	2020-01-27

Customer Contacts

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