FDA.report

Amoena

Primary DI
04026275447476
Brand
Amoena
Company
AMOENA Medizin-Orthopädie-Technik GmbH
Model
010 Strips (04)
Catalog number
010
Device description
Scar Patches
Published
2023-08-17
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
false

Related Records

Product Codes

CodeName
MDAElastomer, Silicone, For Scar Management

Product Code Classifications

CodeDeviceSpecialtyClass
MDAElastomer, Silicone, For Scar ManagementGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04026275447476PrimaryGS10
40262754474768Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04026275447476040262754474764026275447476
4026275447476840262754474768

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
312770613
Device count
4
DM exempt
false
Premarket exempt
true
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 DIBrandModelCatalogPublished
04026275615639Amoena334 Adapt Air Contact Light 2SN 013342025-01-01
04026275615646Amoena334 Adapt Air Contact Light 2SN 023342025-01-01
04026275615653Amoena334 Adapt Air Contact Light 2SN 033342025-01-01
04026275615660Amoena334 Adapt Air Contact Light 2SN 043342025-01-01
04026275615677Amoena334 Adapt Air Contact Light 2SN 053342025-01-01
04026275615684Amoena334 Adapt Air Contact Light 2SN 063342025-01-01
04026275615691Amoena334 Adapt Air Contact Light 2SN 073342025-01-01
04026275615707Amoena334 Adapt Air Contact Light 2SN 083342025-01-01
04026275615714Amoena334 Adapt Air Contact Light 2SN 093342025-01-01
04026275615721Amoena334 Adapt Air Contact Light 2SN 103342025-01-01
04026275615738Amoena334 Adapt Air Contact Light 2SN 113342025-01-01
04026275615745Amoena334 Adapt Air Contact Light 2SN 123342025-01-01
04026275616490Amoena382E Contact 3S EB, 013822024-10-17
04026275616506Amoena382E Contact 3S EB, 023822024-10-17
04026275616513Amoena382E Contact 3S EB, 033822024-10-17
04026275616520Amoena382E Contact 3S EB, 043822024-10-17
04026275616537Amoena382E Contact 3S EB, 053822024-10-17
04026275616544Amoena382E Contact 3S EB, 063822024-10-17
04026275616551Amoena382E Contact 3S EB, 073822024-10-17
04026275616568Amoena382E Contact 3S EB, 083822024-10-17

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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00885914040478RolyanPerformance Health Supply, LLCMDA2026-03-20
00885914040485RolyanPerformance Health Supply, LLCMDA2026-03-20
00358962230806ScarAway Silicone Scar TapeAlliance Pharma Inc.MDA2026-02-19
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
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
00816465020374Silagen Silicone Gel SheetingNewmedical Technology, Inc.MDA2025-08-07
00816465020381Silagen Silicone Gel SheetingNewmedical Technology, Inc.MDA2025-08-07
00816465020398Silagen Silicone Gel SheetingNewmedical Technology, Inc.MDA2025-08-07
00816465020404Silagen Silicone Gel SheetingNewmedical Technology, Inc.MDA2025-08-07
00816465020411Silagen Silicone Gel SheetingNewmedical Technology, Inc.MDA2025-08-07
00816465020572Silagen Silicone Gel SheetingNewmedical Technology, Inc.MDA2025-08-07