GRAFCO

Basic Information

• Brand Name: GRAFCO
• Primary DI: M36831711
• Version / Model: 3171
• Company Name: GF HEALTH PRODUCTS, INC.
• Labeler DUNS: 132016168
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 250
• Record Status: Published
• Publish Date: 2024-07-01
• Public Version: 1
• Public Version Date: 2024-07-09
• Public Version Status: New
• Public Device Record Key: cdc682a6-770f-498a-8121-184611b07ec9

Device Description

DOUBLE SIDED RAZOR BLADE

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: Yes
• 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
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	878.4820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37521	Razor blade	A device with an extremely sharp cutting edge intended to be inserted into a reusable razor to enable hair removal. It comes in various designs, traditionally with two cutting edges (one on either side of the blade's width). Though this device is reusable and designed to be used until blunted, it is for single-patient use to reduce the risk of cross-infection. Some types can be purposely broken into smaller segments to be used like a scalpel to cut tissue, e.g., during certain ophthalmologic surgical procedures. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M36831712	HIBCC	Box	100	In Commercial Distribution
Primary	M36831711	HIBCC
Unit of Use	M36831710	HIBCC