FDA.reportPublic FDA data

Nova Gel

Primary DI
00855638007125
Brand
Nova Gel
Company
STELLEN MEDICAL, LLC
Model
GEL-6505
Catalog number
GEL-6505
Device description
: NovaGel is indicated for use as a scar management dressing on old and new hypertrophic or keloid scars.
Published
2020-10-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDAElastomer, Silicone, For Scar Management

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDAElastomer, Silicone, For Scar ManagementGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855638007132PackageGS15In Commercial Distribution
00855638007125PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855638007132008556380071328556380071320855638007132
00855638007125008556380071258556380071250855638007125

GMDN Terms#

Term, Definition table
TermDefinition
Scar management dressing, reusableA non-sterile covering made of a silicone-based material (e.g., silicone gel) intended to be applied directly to the skin for the management of hypertrophic or keloid scars. The device is typically in the form of an elastic sheet that occludes the skin to hydrate and reduce red, dark, or raised scars resulting from surgery, accidents, cuts, burns, or other injuries. The device may be self-adhesive or fixed by tape; it may be washable. This is a reusable device after appropriate cleaning.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width6Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
801160037
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00855638007095GlucanPro GPC-0085GPC-00852020-10-22
00855638007118GlucanPro GPC-0025GPC-00252020-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05000223482589CICA CARESMITH & NEPHEW MEDICAL LIMITEDMDA2026-04-30
05000223502157CICA CARESMITH & NEPHEW MEDICAL LIMITEDMDA2026-04-30
00860015727305KegelStar Port IncMDA2026-04-25
00885914040461RolyanPerformance Health Supply, LLCMDA2026-03-20
00885914040478RolyanPerformance Health Supply, LLCMDA2026-03-20
00885914040485RolyanPerformance Health Supply, LLCMDA2026-03-20
00358962230806ScarAway Silicone Scar TapeAlliance Pharma Inc.MDA2026-02-19
00850072068770CeladiaBiowound Solutions, Inc.MDA2025-12-18
00850072068787CeladiaBiowound Solutions, Inc.MDA2025-12-18
10850072068777CeladiaBiowound Solutions, Inc.MDA2025-12-18
10850072068784CeladiaBiowound Solutions, Inc.MDA2025-12-18
04719884330269H&HTRONJEN MEDICAL TECHNOLOGY INC.MDA2025-12-12
04719884330368H&HTRONJEN MEDICAL TECHNOLOGY INC.MDA2025-12-12
04719884333765H&HTRONJEN MEDICAL TECHNOLOGY INC.MDA2025-12-11
06972949026110SensifineHangzhou R&L Medical Device Co., LtdMDA2025-12-08
16972949026117SensifineHangzhou R&L Medical Device Co., LtdMDA2025-12-08
00816465020008NewGel+ Silicone Gel SheetingNewmedical Technology, Inc.MDA2025-08-07
00816465020015NewGel+ Silicone Gel SheetingNewmedical Technology, Inc.MDA2025-08-07
00816465020046NewGel+UV Silicone Gel for Scars + SPF30Newmedical Technology, Inc.MDA2025-08-07
00816465020213Silagen 100% Pure Silicone GelNewmedical Technology, Inc.MDA2025-08-07
00816465020220Silagen 100% Pure Silicone GelNewmedical Technology, Inc.MDA2025-08-07
00816465020237Silagen Silicone Gel for Scars + SPF30 UV ProtectionNewmedical Technology, Inc.MDA2025-08-07
00816465020244Silagen Silicone Gel for Scars + SPF30 UV ProtectionNewmedical Technology, Inc.MDA2025-08-07
00816465020299NewGel+E Advanced Silicone Gel for ScarsNewmedical Technology, Inc.MDA2025-08-07
00816465020305NewGel+E Advanced Silicone Gel for ScarsNewmedical Technology, Inc.MDA2025-08-07
00816465020329NewGel+ Silicone Gel SheetingNewmedical Technology, Inc.MDA2025-08-07
00816465020336NewGel+ Silicone Gel SheetingNewmedical Technology, Inc.MDA2025-08-07
00816465020343NewGel+ Silicone Gel SheetingNewmedical Technology, Inc.MDA2025-08-07
00816465020350NewGel+ Silicone Gel SheetingNewmedical Technology, Inc.MDA2025-08-07
00816465020367Silagen Silicone Gel SheetingNewmedical Technology, Inc.MDA2025-08-07