Leica Biosystems

Basic Information

• Brand Name: Leica Biosystems
• Primary DI: 10849832002946
• Version / Model: 000000000003803100
• Company Name: Leica Biosystems Richmond, Inc.
• Labeler DUNS: 082930884
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2024-12-27
• Public Version: 1
• Public Version Date: 2025-01-06
• Public Version Status: New
• Public Device Record Key: cd2282ce-97ef-481c-8937-339e9cc5c8b4

Device Description

Frostbite

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
LEA	PRESERVATIVE, CYTOLOGICAL	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62970	Histology tissue cassette IVD, laboratory processing, single-use	A small device intended to be used in the laboratory to support/contain clinical tissue specimens (e.g., biopsy samples) to facilitate specimen processing [e.g., fixation (encapsulation in paraffin wax), dehydration, infiltration] in preparation for subsequent cytological or histological examination, and storage. It is in the form of a plastic container, with or without a lid, with drainage holes to maximize fluid exposure during tissue submersion in a parent device into which the container is loaded. It may, in addition, include a fenestrated insert to hold and prevent the loss of a smaller specimens. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00849832002949	GS1
Primary	10849832002946	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify

Storage Conditions

• Type: Special Storage Condition, Specify
• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius