HEMOCELL

Basic Information

• Brand Name: HEMOCELL
• Primary DI: 16940610101760
• Version / Model: 2×2cm
• Company Name: Huizhou Foryou Medical Devices Co., Ltd.
• Labeler DUNS: 529904325
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-24
• Public Version: 1
• Public Version Date: 2021-04-01
• Public Version Status: New
• Public Device Record Key: 60ffb042-86d3-4f8c-8fb6-4ce4efe46cfc

Device Description

HEMOCELL Soluble Dental Gauze Dressing

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MGQ	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
63636	General oral wound dressing, non-animal-derived, sterile	A sterile device intended to be used as a protective cover for the general oral mucosa to treat surgical or traumatic wounds/lesions in the mouth. It consists primarily of one or more plant-derived and/or (bio)synthetic compound(s) and is supplied in various forms (e.g., plug, sheet, gel, fluid, spray) for use in the home or a clinical setting. After application, this device cannot be reused.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	16940610101760	GS1
Package	26940610101767	GS1	Box	20	In Commercial Distribution
Package	36940610101764	GS1	Case	100	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]