TCC-EZ®

Basic Information

• Brand Name: TCC-EZ®
• Primary DI: 00809958000366
• Version / Model: TCC2SAW
• Catalog Number: TCC2SAW
• Company Name: ACELL, INC.
• Labeler DUNS: 137258252
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-23
• Public Version: 2
• Public Version Date: 2023-06-08
• Public Version Status: Update
• Public Device Record Key: 8ae0e210-6923-4e06-994f-5db106f580a3

Device Description

TOTAL CONTACT CAST SYSTEM - Cast Removal Saw.

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: Yes
• 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: 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
LGH	INSTRUMENT, CAST REMOVAL, AC-POWERED	Orthopedic	888.5960	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15774	Cast cutter blade	A surgical cutting device intended to be used with a cast removal tool (cast cutter) to provide the cutting edge for cutting through cast material so that this can be removed from the patient. It is formed as a thin, rounded, half moon-like, or circular blade with serrated teeth around its cutting edge. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00809958000366	GS1

Customer Contacts

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