GlucanPro

Primary DI
00855638007095
Brand
GlucanPro
Company
STELLEN MEDICAL, LLC
Model
GPC-0085
Catalog number
GPC-0085
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.
Published
2020-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or BiologicUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002077000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002077000GLUCANPRO CREAMBrennen Medical, Inc.2000-10-02MGQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855638007095PackageGS112In Commercial Distribution
00855638007088PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855638007095008556380070958556380070950855638007095
00855638007088008556380070888556380070880855638007088

GMDN Terms#

Term, Definition table
TermDefinition
Skin moisture barrier dressingA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight85Gram

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
651-426-1496customerservice@stellenmedical.com

Regulatory Flags#

DUNS number
801160037
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855638007125Nova GelGEL-6505GEL-65052020-10-22
M070PR02051ProformixPR-0205PR-02052015-04-01
M070PR04071ProformixPR-0407PR-040742015-04-01
M070PR05101ProformixPR-0510PR-05102015-04-01
00855638007002ProLayer Xenograft3102-21252017-07-06
00855638007019ProLayer Xenograft3102-21442017-07-06
00855638007026ProLayer Xenograft3102-21472017-07-06
00855638007033ProLayer Xenograft3102-21512017-07-06
00855638007064GlucanPro 3000GPC3-0180GPC3-01802020-10-22
00855638007088GlucanPro GPC-0085GPC-00852020-10-22
00855638007101GlucanPro GPC-0025GPC-00252020-10-22
00855638007040GlucanPro 3000GPC3-0035GPC3-00352020-10-22
00855638007149Brennen Skin Graft Mesher1:12022-08-10
00855638007156Brennen Skin Graft Mesher6:12022-08-10
00855638007163Brennen Skin Graft Mesher4:12022-08-10
00855638007170Brennen Skin Graft Mesher3:12022-08-10
00855638007187Brennen Skin Graft Mesher2:12022-08-10
00855638007194Brennen Skin Graft MesherPC2022-08-10
00855638007071GlucanPro 3000GPC3-0180GPC3-01802020-10-22
00855638007118GlucanPro GPC-0025GPC-00252020-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00368040753141Promiseb Topical CreamPrimus Pharmaceuticals, Inc.MGQ2026-05-01
00850058790114RV-X1Gel4med, Inc.MGQ2025-10-17
00850058790121RV-X1Gel4med, Inc.MGQ2025-10-17
00850058790138G4Derm PlusGel4med, Inc.MGQ2025-10-17
00850058790145G4Derm PlusGel4med, Inc.MGQ2025-10-17
00850058790152G4Derm PlusGel4med, Inc.MGQ2025-10-17
00383160000104Dash TopicAIM MEDICAL INC.MGQ2025-05-12
00850058790060SuprelloGel4med, Inc.MGQ2025-03-25
00850058790084SuprelloGel4med, Inc.MGQ2025-03-25
00850058790091SuprelloGel4med, Inc.MGQ2025-03-25
00860013569907MuGardSoleva Pharma LLCMGQ2025-02-28
00743537000791BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000814BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000838BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000852Burn StopWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000913Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000937Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000951Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000975Burn StopWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000999Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537001019Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537001033Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537001057Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537001071Burn StopWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537001095Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000784BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000807BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000821BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000845Burn StopWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000906Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01