MEEK set machine driven complete

Basic Information

• Brand Name: MEEK set machine driven complete
• Primary DI: 08717903490396
• Version / Model: 3.MD
• Catalog Number: 3.MD
• Company Name: Humeca B.V.
• Labeler DUNS: 489831498
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-20
• Public Version: 1
• Public Version Date: 2025-05-28
• Public Version Status: New
• Public Device Record Key: 32f10c67-093c-4171-ac1f-affa5709a908

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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GFD	Dermatome	General, Plastic Surgery	878.4820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13614	Skin graft mesher	A manual surgical device used to perforate a skin graft (a section of donor skin from another part of the patient's body) with a pattern of lacerations (cuts) before the skin is grafted to the area being treated on the patient. The skin may be placed on a skin graft carrier to better support it and will typically be run through an instrument with a row of cutting wheels, or be subjected to a rolling drum with a handle and cutting blades, to improve graft stretch and permeability and facilitate graft conformity and healing. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	08717903490495	GS1
Primary	08717903490396	GS1