HypoFoam

Basic Information

• Brand Name: HypoFoam
• Primary DI: 00860013471606
• Version / Model: 1000
• Company Name: TyTek Medical Inc.
• Labeler DUNS: 078589992
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-17
• Public Version: 1
• Public Version Date: 2025-06-25
• Public Version Status: New
• Public Device Record Key: f463cbab-5d80-46e8-8356-545c9b5b5ace

Device Description

Single-use foam block for use with HypoHolder system

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12236	Surgical instrument interim-placement holder, single-use	A device intended to be used in the operating room (OR) by staff to safely hold a hand-held, manual, surgical instrument(s) [e.g., needle, scalpel, scissors, robotic system instrument hand-held remote controller] when not in use during surgery, to avoid damage to the instrument, maintain its sterility, and/or for temporary storage (e.g., to enable easy transfer/handling of the instrument at reduced risk of injury). It is available in various forms (e.g., rack, puncture cushion, telescopic tube, magnetic mat), and may be attached to a surgical drape; it is not a numbered tray and is not intended for counting of sharps. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860013471606	GS1