FDA.report

Mepiform®

Primary DI
07323190105229
Brand
Mepiform®
Company
Mölnlycke Health Care AB
Model
293288
Device description
Mepiform 2x3in/5x7,5cm, CVS
Published
2020-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

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
00050428305072PackageGS13Not in Commercial Distribution
07323190105229PackageGS15Not in Commercial Distribution
07323190127108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00050428305072000504283050720504283050720050428305072
07323190105229073231901052297323190105229
07323190127108073231901271087323190127108

GMDN Terms

TermDefinition
Scar management dressing, single-use, sterileA sterile covering made of, or coated with, a silicone-based substance (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 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. After application, this device cannot be reused.

Device Sizes

TypeValueUnit
Height0Millimeter
Length0Millimeter
Width0Millimeter

Sterilization Methods

Method

Regulatory Flags

DUNS number
631770658
Device count
1
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

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07333350625993Mepore®3320002026-05-23
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07323190091218Biogel® PI Micro Indicator® System483602026-03-02
07323190091263Biogel® PI Micro Indicator® System483652026-03-02
07323190091300Biogel® PI Micro Indicator® System483702026-03-02
07323190091348Biogel® PI Micro Indicator® System483752026-03-02
07323190091379Biogel® PI Micro Indicator® System483802026-03-02
07323190091454Biogel® PI Micro Indicator® System483852026-03-02
07333350045845Mepilex® Transfer2948992026-02-26
07333350416249Mepilex® Transfer2945992026-02-26
07333350703745Tortoise™ Turning & positioning system14008102026-02-11
07333350636012Tortoise™ Turning & positioning system14008112026-02-11
07333350692483Mepilex®2941992026-01-25
07333350865382Mepilex® Lite2841902026-01-25
07333350291266Mepilex® Lite2843902026-01-25
07333350384036Mepilex®2942992026-01-25
07333350018757Mepilex® Lite2840902026-01-25
07333350805357Mepilex®2944992026-01-25
07333350140922Mepilex®2940902026-01-25

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
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