FDA.reportPublic FDA data

Silagen 100% Pure Silicone Gel

Primary DI
00816465020220
Brand
Silagen 100% Pure Silicone Gel
Company
Newmedical Technology, Inc.
Model
6130
Device description
6130 Silagen Pure Silicone Gel, 1.0 oz. (30 gram), 1 bottle/package
Published
2025-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00816465020220PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816465020220008164650202208164650202200816465020220

GMDN Terms#

Term, Definition table
TermDefinition
Scar-management dressing, single-useA covering/substance made of, or coated with, a synthetic polymer 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 a flexible or elastic sheet/film, foam, or gel that occludes the skin to hydrate and reduce/prevent red, dark, or raised scars resulting from surgery, accidents, cuts, burns, or other injuries. The device may be self-adhesive or fixed by tape; devices/accessories associated with application may be included (e.g., massage ball). After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature59 Degrees Fahrenheit80 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
847-412-1000regulatory@newmedical.com

Regulatory Flags#

DUNS number
787828669
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816465020008NewGel+ Silicone Gel SheetingNG-3652025-08-07
00816465020015NewGel+ Silicone Gel SheetingNG-1652025-08-07
00816465020046NewGel+UV Silicone Gel for Scars + SPF3080152025-08-07
00816465020213Silagen 100% Pure Silicone Gel61152025-08-07
00816465020237Silagen Silicone Gel for Scars + SPF30 UV Protection62302025-08-07
00816465020244Silagen Silicone Gel for Scars + SPF30 UV Protection62152025-08-07
00816465020299NewGel+E Advanced Silicone Gel for ScarsNGO-8102025-08-07
00816465020305NewGel+E Advanced Silicone Gel for ScarsNGO-8002025-08-07
00816465020329NewGel+ Silicone Gel SheetingNG-3012025-08-07
00816465020336NewGel+ Silicone Gel SheetingNG-301S2025-08-07
00816465020343NewGel+ Silicone Gel SheetingNG-3802025-08-07
00816465020350NewGel+ Silicone Gel SheetingNG-3202025-08-07
00816465020367Silagen Silicone Gel Sheeting71602025-08-07
00816465020374Silagen Silicone Gel Sheeting73602025-08-07
00816465020381Silagen Silicone Gel Sheeting71632025-08-07
00816465020398Silagen Silicone Gel Sheeting73632025-08-07
00816465020404Silagen Silicone Gel Sheeting71642025-08-07
00816465020411Silagen Silicone Gel Sheeting73642025-08-07
00816465020572Silagen Silicone Gel Sheeting71012025-08-07
00816465020589Silagen Silicone Gel Sheeting73332025-08-07

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
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
00816465020374Silagen Silicone Gel SheetingNewmedical Technology, Inc.MDA2025-08-07