HYGITECH

Basic Information

• Brand Name: HYGITECH
• Primary DI: 03615140005197
• Version / Model: HY-0421
• Catalog Number: HY-0421
• Company Name: HYGITECH
• Labeler DUNS: 279456896
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-16
• Public Version: 1
• Public Version Date: 2020-12-24
• Public Version Status: New
• Public Device Record Key: e308cbd6-4198-4a68-b76d-c09ee1719c01

Device Description

Surgeon kit HYGITECH Reference: HY-0421 The SURGEON kit is specifically designed for surgeries with the surgeon operating on his own. It contains all the protection wear needed for the surgeon, as well as a surgical brush and towels. It is composed of 12 items. 1 Surgical hat 1 Bouffant cap 1 Tie-on mask 1 Pair of overshoes 1 Surgical brush with nail cleaner 3 Paper hand-towels 1 Surgical gown with cotton cuffs 1 Wrapping paper

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: Yes
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: Yes

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

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

GMDN Terms

Code	Name	Definition	Implantable	Status
11171	Denture repair kit, professional	A collection of devices used in dentistry by a dentist or dental laboratory technician to repair cracks or breaks in a denture. It will contain the necessary materials and components, e.g., resins, adhesives/glues, mixing utensils, and an applicator. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	03615140005203	GS1	Carton	10	In Commercial Distribution
Primary	03615140005197	GS1