TCC-EZ®

Basic Information

• Brand Name: TCC-EZ®
• Primary DI: 00809958004616
• Version / Model: TCC21100
• Catalog Number: TCC2-1100
• 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: 6
• Public Version Date: 2023-06-08
• Public Version Status: Update
• Public Device Record Key: b10a2ddf-5151-4c98-96cc-2fc8a7efc6c7

Device Description

TCC-EZ® TOTAL CONTACT CAST SYSTEM - Regular Boot

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: 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
ITG	BANDAGE, CAST	Physical Medicine	890.3025	1

GMDN Terms

Code	Name	Definition	Implantable	Status
10667	Cast boot	A boot-like device designed to be attached around a leg cast to protect and support the cast, and to assist with patient mobility. This device is generally equipped with a waterproof covering, an outer sole for walking, and closures for easy application and removal. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00809958004616	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			10cm x 3.5cm
Device Size Text, specify			4" W x 3.3125"H