HYGITECH

Basic Information

• Brand Name: HYGITECH
• Primary DI: 03615140003414
• Version / Model: HY-63115
• Catalog Number: HY-63115
• Company Name: HYGITECH
• Labeler DUNS: 279456896
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-25
• Public Version: 4
• Public Version Date: 2021-06-22
• Public Version Status: Update
• Public Device Record Key: f2dd1ce9-8f02-40e0-b24b-28405ed37947

Device Description

This polyethylene x-ray bouffant cover will offer maximum protection against cross-contamination when covering your x-ray material, microscopes or dental lights. Internal diameter: 20cm. External diameter: 50cm.

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
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	878.4040	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62934	Surgical dressing/drape kit, single-use	A collection of various types of patient drapes, dressings, covers and/or towels intended to be used to facilitate a surgical procedure. It does not include any pharmaceuticals, surgical instruments, surgical tubing, or mechanically functional devices and is not dedicated to catheterization support. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	03615140003421	GS1	Box	50	In Commercial Distribution
Primary	03615140003414	GS1
Package	03615140003438	GS1	Carton	2	In Commercial Distribution