N/A (Approved Vendor)

Basic Information

• Brand Name: N/A (Approved Vendor)
• Primary DI: 10194484321700
• Version / Model: 21RK91
• Company Name: GRAINGER INTERNATIONAL, INC.
• Labeler DUNS: 053618240
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2025-08-11
• Public Version: 1
• Public Version Date: 2025-08-19
• Public Version Status: New
• Public Device Record Key: 487c0ac1-9854-4381-b79e-293faf2bff93

Device Description

Cassette,1.63 In,PK500

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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IDZ	Cassettes, Tissue	Pathology	864.3010	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
Package	20194484321707	GS1	box	4	In Commercial Distribution
Primary	10194484321700	GS1
Unit of Use	00194484321703	GS1