Embedding Cassette

Basic Information

• Brand Name: Embedding Cassette
• Primary DI: 00810049680299
• Version / Model: EC0104AXS
• Company Name: TYPENEX MEDICAL LLC
• Labeler DUNS: 600850213
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 750
• Record Status: Published
• Publish Date: 2022-11-16
• Public Version: 1
• Public Version Date: 2022-11-24
• Public Version Status: New
• Public Device Record Key: 2178db5b-c74a-4dbc-8bb6-2c3aed723281

Device Description

Biopsy, One Compartment, 0.26 x 0.26 mm, 45°, Lid Attached, Front Hinge, Aqua, Sleeved

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
63791	Tissue embedding mould IVD, single-use	A plastic container of square or rectangular shape intended to be used to embed tissue specimens into an embedding medium (e.g., paraffin wax) to form a solid block, which is subsequently cut into thin sections for processing and analysis of the tissue specimen. It is typically made of synthetic polymer materials (e.g., plastic) This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810049680299	GS1
Unit of Use	00812269034531	GS1