Rowley Biochemical Crystal Violet, 2% Aqueous

Basic Information

• Brand Name: Rowley Biochemical Crystal Violet, 2% Aqueous
• Primary DI: SO1107852042008
• Version / Model: 1
• Catalog Number: SO-1107
• Company Name: TRANSENE COMPANY, INC.
• Labeler DUNS: 044815983
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-16
• Public Version: 1
• Public Version Date: 2019-09-24
• Public Version Status: New
• Public Device Record Key: fa4a8165-4146-4a4a-a699-249cb4368273

Device Description

Crystal Violet, 2% Aqueous Solution

Device Characteristics

• Single Use: No
• 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: Yes
• 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	SO1107852042008	HIBCC

Device Sizes

Type	Value	Unit	Text
Total Volume	1	Gallon
Total Volume	1	Quart
Total Volume	1	Pint
Total Volume	8	Fluid Ounce
Total Volume	4	Fluid Ounce