GRAFCO

Basic Information

• Brand Name: GRAFCO
• Primary DI: M36883751
• Version / Model: 8375
• Company Name: GF HEALTH PRODUCTS, INC.
• Labeler DUNS: 132016168
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-24
• Public Version: 1
• Public Version Date: 2020-09-01
• Public Version Status: New
• Public Device Record Key: 99634045-3001-4a1b-ac9c-c709ad073052

Device Description

Stainless Steel Sterilizer, Dry Heat

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
KMH	Sterilizer, Dry Heat	General Hospital	880.6870	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35364	Dry-heat sterilizer	A mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from non-heat sensitive medical devices and related products using dry heat sterilization. It typically includes a treatment chamber with shelves where the devices to be sterilized are placed, usually after cleaning of gross debris; a heat source (e.g., electric heaters); and controls to regulate the time and/or temperature of the procedure. The heat may flow into the chamber either by natural convection or using forced air to accelerate and/or make more uniform the process (e.g., fans, high-speed hot air jets). The device is available in stand-alone (bulk) and tabletop units.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M36883751	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K771070	000