Alpha-Tec Systems

Basic Information

• Brand Name: Alpha-Tec Systems
• Primary DI: 00816085020792
• Version / Model: 0
• Catalog Number: 0003529
• Company Name: Alpha-TEC Systems, Inc.
• Labeler DUNS: 103105524
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-21
• Public Version: 1
• Public Version Date: 2022-07-29
• Public Version Status: New
• Public Device Record Key: 3073244f-c929-4dcb-8c86-cb773205b438

Device Description

Potassium Permanganate Stain 1x250ml

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: No
• 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
JTS	Stains, Microbiologic	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	00816085020792	GS1

Premarket Submissions

Submission Number	Supplement Number
K881698	000