GRAFCO

Basic Information

• Brand Name: GRAFCO
• Primary DI: M3684001GF1
• Version / Model: 4001GF
• Catalog Number: 4001GF
• Company Name: GF HEALTH PRODUCTS, INC.
• Labeler DUNS: 132016168
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-01
• Public Version: 3
• Public Version Date: 2022-12-08
• Public Version Status: Update
• Public Device Record Key: 6ec5da1c-b3ab-4531-a1af-86d07ef199c4

Device Description

Ultrasound Gel

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	892.1570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
15321	Skin topical coupling gel	A medium designed to be applied to a patient's unbroken skin surface (excludes the eye surface) to provide a coupling between an analytical or therapeutic device (e.g., ultrasound transducer, optical glucose monitoring system, transcutaneous electrical stimulator) and the patient, allowing for the emission and reception of energy/signals (e.g., electrical current, light) that pass through the skin during an examination or treatment. It is in the form of a fluid-like gel that may also assist in moving the parent device smoothly over the skin. It may be used by a healthcare professional in a clinical setting and layperson in the home. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M3684001GF2	HIBCC	Box	12	In Commercial Distribution
Primary	M3684001GF1	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K955246	000

Device Sizes

Type	Value	Unit	Text
Total Volume	250	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: – 95 Percent (%) Relative Humidity