Epredia

Basic Information

• Brand Name: Epredia
• Primary DI: 00673693085465
• Version / Model: Pen-Fix™
• Catalog Number: 6101
• Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY
• Labeler DUNS: 929504710
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-24
• Public Version: 1
• Public Version Date: 2024-08-01
• Public Version Status: New
• Public Device Record Key: ceebbd71-0235-438f-a6ff-b28775a79879

Device Description

Fixation is the initial and most important step of histology specimen preparation in pathology. 10% Neutral Buffered Formalin is the most used fixative in the histology laboratory, but in certain circumstances, other fixatives may be desired according to tissue type or subsequent pretreatment or staining technique. Pen-Fix is an alcoholic formalin variation with the addition of a proprietary buffer salt.

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: 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
LDZ	Fixative, Alcohol Containing	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57758	Neutral buffered formalin IVD	A neutral buffered formalin solution intended to be used as a fixative in the processing of biological tissues or clinical specimens. Some formulations may contain additional components such as zinc, alcohol, and/or eosin.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00673693085465	GS1