HYGITECH

Basic Information

• Brand Name: HYGITECH
• Primary DI: 03615140000321
• Version / Model: HY-055
• Catalog Number: HY-055
• Company Name: HYGITECH
• Labeler DUNS: 279456896
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-15
• Public Version: 2
• Public Version Date: 2022-11-09
• Public Version Status: Update
• Public Device Record Key: ca625d7e-6315-4684-afd4-fc1cd2823f2a

Device Description

Convenient - Easy to tear off and apply Its delicate adhesive layer makes Hygifilm easily removable without damaging your equipment or walls. - Supplied as a roll of 10cm x 14,5xm pre-perforated adhesive sheets, presented in a dispenser box. In order to prevent cross-contamination, all surfaces that are likely to be touched by the medical team during the surgery should be covered. Hygifilm helps fight cross-contamination by isolating all surfaces that are impossible or difficult to autoclave: dental light handles, computer mice, computer control panel, keyboards and telephones...

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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
10035	Skin surface device adhesive	A substance (e.g., gel, aerosol) intended to adhere a medical device (e.g., dressing, ostomy device, aesthetic restoration prosthesis) to the skin surface; it is not intended for invasive/surgical use but may be intended for other non-patient contact uses. It may be used in the home or healthcare facility. 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	03615140000338	GS1	Carton	25	In Commercial Distribution
Primary	03615140000321	GS1