Identity
- Trade Name
- GlucanPro 3000 FDA UDI
- Generic Name
- Dry skin moisture barrier dressing FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- GPC3-0180 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- GPC3-0180 FDA UDI
- Primary DI / UDI-DI
- 00855638007064 FDA UDI
- 510(k) Number
- K002077 FDA UDI
- FDA Product Code
- MGQ FDA UDI
- GMDN Term
- Dry skin moisture barrier dressing FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 18 Fluid Ounce FDA UDI
Category: Dry skin moisture barrier dressing
GlucanPro 3000 by Stellen Medical, LLC — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K002077 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Stellen Medical, LLC
Sources (1)
- FDA UDI c2026c70-d460-4fa9-852d-3fc1f4c9d49e 37 fields · synced May 30, 2026