GlucanPro 3000

Basic Information

• Brand Name: GlucanPro 3000
• Primary DI: 00855638007064
• Version / Model: GPC3-0180
• Catalog Number: GPC3-0180
• Company Name: STELLEN MEDICAL, LLC
• Labeler DUNS: 801160037
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-22
• Public Version: 2
• Public Version Date: 2022-12-08
• Public Version Status: Update
• Public Device Record Key: c2026c70-d460-4fa9-852d-3fc1f4c9d49e

Device Description

GlucanPro Cream is intended to be used as an aid in the management of superficial abrasions, scrapes, cuts and lacerations; minor burns and scalds, partial and full thickness wounds, and irritations of the skin. GlucanPro Cream may also be used, under the supervision/direction of a health care professional for pressure ulcers; venous, diabetic, and arterial ulcers; partial thickness burns; donor graft sites; and surgical wounds. GlucanPro Cream provides a moist environment which supports in the autolytic debridement of wounds with scattered areas of necrosis and slough.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• 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: No
• 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
46206	Dry skin moisture barrier dressing	A substance (e.g., cream, paste, ointment, gel, foam, or aerosol) intended to be applied to the skin/external mucosa (e.g., lips) to provide a protective moisture barrier to the external environment and/or to soften and sooth the skin. It is typically used for conditions such as dry, itchy, flaky, cracked, denuded, irritated or sun-damaged skin, cheilitis, and/or herpetic skin lesions. It may be intended for sensitive areas (e.g., areolar, perianal, lips, ears), dry skin and/or deep fissures (e.g., on the feet); it may include a disposable applicator. 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	00855638007071	GS1	Box	4	In Commercial Distribution
Primary	00855638007064	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K002077	000

Device Sizes

Type	Value	Unit	Text
Total Volume	18	Fluid Ounce