TCFO INFLATABLE W/ACCESS KIT 25/CS

Basic Information

• Brand Name: TCFO INFLATABLE W/ACCESS KIT 25/CS
• Primary DI: 00733657277418
• Version / Model: D51598
• Catalog Number: 2970018887
• Company Name: ALIMED, INC.
• Labeler DUNS: 056007248
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2022-12-01
• Public Version: 3
• Public Version Date: 2024-02-26
• Public Version Status: Update
• Public Device Record Key: dbe81d31-4fa3-4a7f-9730-0e616eaccaa6

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
ILH	SPLINT, HAND, AND COMPONENTS	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41457	Hand orthosis	A prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus intended to be used to encompass the whole or part of the hand to support, align, prevent, or correct deformities/injuries or to improve function of the hand. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00733657277418	GS1
Unit of Use	00733657300024	GS1

Customer Contacts

• Phone: [phone] ext. 0
• Email: [email protected]