GlucanPro GPC-0085

GUDID 00855638007095

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.

STELLEN MEDICAL, LLC

Skin moisture barrier dressing Skin moisture barrier dressing Skin moisture barrier dressing Skin moisture barrier dressing Skin moisture barrier dressing Skin moisture barrier dressing Skin moisture barrier dressing Skin moisture barrier dressing Skin moisture barrier dressing Skin moisture barrier dressing Skin moisture barrier dressing Skin moisture barrier dressing Skin moisture barrier dressing Dry skin moisture barrier dressing Dry skin moisture barrier dressing Dry skin moisture barrier dressing Dry skin moisture barrier dressing Dry skin moisture barrier dressing Dry skin moisture barrier dressing Dry skin moisture barrier dressing Dry skin moisture barrier dressing

• Primary Device ID: 00855638007095
• NIH Device Record Key: 5aaa890c-5bf9-4a8c-99de-de3e40838ff7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GlucanPro
• Version Model Number: GPC-0085
• Catalog Number: GPC-0085
• Company DUNS: 801160037
• Company Name: STELLEN MEDICAL, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 651-426-1496
• Email: customerservice@stellenmedical.com
• Phone: 651-426-1496
• Email: customerservice@stellenmedical.com
• Phone: 651-426-1496
• Email: customerservice@stellenmedical.com
• Phone: 651-426-1496
• Email: customerservice@stellenmedical.com
• Phone: 651-426-1496
• Email: customerservice@stellenmedical.com
• Phone: 651-426-1496
• Email: customerservice@stellenmedical.com
• Phone: 651-426-1496
• Email: customerservice@stellenmedical.com
• Phone: 651-426-1496
• Email: customerservice@stellenmedical.com
• Phone: 651-426-1496
• Email: customerservice@stellenmedical.com
• Phone: 651-426-1496
• Email: customerservice@stellenmedical.com
• Phone: 651-426-1496
• Email: customerservice@stellenmedical.com
• Phone: 651-426-1496
• Email: customerservice@stellenmedical.com
• Phone: 651-426-1496
• Email: customerservice@stellenmedical.com
• Phone: 651-426-1496
• Email: customerservice@stellenmedical.com
• Phone: 651-426-1496
• Email: customerservice@stellenmedical.com
• Phone: 651-426-1496
• Email: customerservice@stellenmedical.com
• Phone: 651-426-1496
• Email: customerservice@stellenmedical.com
• Phone: 651-426-1496
• Email: customerservice@stellenmedical.com
• Phone: 651-426-1496
• Email: customerservice@stellenmedical.com
• Phone: 651-426-1496
• Email: customerservice@stellenmedical.com
• Phone: 651-426-1496
• Email: customerservice@stellenmedical.com

Device Dimensions

• Weight: 85 Gram
• Weight: 85 Gram
• Weight: 85 Gram
• Weight: 85 Gram
• Weight: 85 Gram
• Weight: 85 Gram
• Weight: 85 Gram
• Weight: 85 Gram
• Weight: 85 Gram
• Weight: 85 Gram
• Weight: 85 Gram
• Weight: 85 Gram
• Weight: 85 Gram
• Weight: 85 Gram
• Weight: 85 Gram
• Weight: 85 Gram
• Weight: 85 Gram
• Weight: 85 Gram
• Weight: 85 Gram
• Weight: 85 Gram
• Weight: 85 Gram

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855638007088 [Primary]
GS1	00855638007095 [Package]; Contains: 00855638007088; Package: Box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002077

FDA Product Code

• MGQ: Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-30
• Device Publish Date: 2020-10-22

On-Brand Devices [GlucanPro ]

• 00855638007118: GlucanPro Cream is intended to be used as an aid in the management of superficial abrasions, scr
• 00855638007095: GlucanPro Cream is intended to be used as an aid in the management of superficial abrasions, scr