KOVA

Basic Information

• Brand Name: KOVA
• Primary DI: 00850015517037
• Version / Model: 84653
• Catalog Number: 84653
• Company Name: KOVA INTERNATIONAL, INC.
• Labeler DUNS: 078780990
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-09
• Public Version: 1
• Public Version Date: 2020-03-17
• Public Version Status: New
• Public Device Record Key: e14c2846-f8cf-4d61-8d09-d7d10994e5ef

Device Description

KOVA Refractrol SP, Normal Level

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ICF	Crystal Violet For Histology	Hematology	864.1850	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43587	Biological stain IVD	A single chemical agent, dye or solution intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms, in a clinical specimen, for their subsequent visualization, examination, identification and/or differentiation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850015517037	GS1

Customer Contacts

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