MedE-Kast®

Basic Information

• Brand Name: MedE-Kast®
• Primary DI: 00809958009017
• Version / Model: TCC2FCT03
• Catalog Number: TCC2FC045
• 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: 4
• Public Version Date: 2023-06-08
• Public Version Status: Update
• Public Device Record Key: 392eee7c-b28b-4c24-966f-eb689d76d76f

Device Description

MedE-Kast® 3" Roll Fiberglass Cast Tape

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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
ITG	BANDAGE, CAST	Physical Medicine	890.3025	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33056	Cast construction material	A plastic, fibreglass, or plaster-containing substance (or other material) that is applied in layers around an injured body appendage to construct a stiff dressing (cast) in order to immobilize fractured bones, diseased joints, or painful sprains. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00809958009017	GS1

Customer Contacts

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