FDA.reportPublic FDA data

Mepilex® Border Flex

Primary DI
07323190193134
Brand
Mepilex® Border Flex
Company
Mölnlycke Health Care AB
Model
595200
Device description
Mepilex Border Flex 7.5x7.5 10pack BRU
Published
2022-10-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NACDressing, wound, hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07333350412920PackageGS15In Commercial Distribution
07333350519797PackageGS110In Commercial Distribution
07323190193134PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07333350412920073333504129207333350412920
07333350519797073333505197977333350519797
07323190193134073231901931347323190193134

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, absorbent, non-antimicrobialA wound covering typically in the form of a multi-layered pad having a material or substance on its skin-contact surface (e.g., silicone gel), or designed to be soaked in saline prior to application, to prevent adherence to the wound bed thereby decreasing wound trauma potential; it does not contain an antimicrobial agent. It is typically used to absorb wound blood/exudates while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites; it is not a dedicated burn dressing. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
+46737733775pedro.lopes@molnlycke.com

Regulatory Flags#

DUNS number
631770658
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
07333350377205Mepore®3319002026-05-23
07333350625993Mepore®3320002026-05-23
07333350050498Mestopore®6651002026-05-06
07333350065126Mepore® Pro6711202026-05-06
07333350436575Mepore® Pro6811402026-05-06
07333350477103Mepore® Pro6713202026-05-06
07333350627041Mepore® Pro6712202026-05-06
07333350862176Mepore® Pro6709202026-05-06
07333350872489Mepore®6715002026-05-06
07333350904104Mestopore®6650002026-05-06
07333350917159Mepore® Pro6710202026-05-06
07333350976712Tubigrip®14362026-05-06
07333350996147Mepore®6709702026-05-06
05060097937790Biogel® PI408552022-10-21
05060097937806Biogel® PI408602022-10-21
05060097937813Biogel® PI408652022-10-21
05060097937820Biogel® PI408702022-10-21
05060097937837Biogel® PI408752022-10-21
05060097937844Biogel® PI408802022-10-21
05060097937851Biogel® PI408852022-10-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00197998367427Solventum™ Adaptic™Solventum Germany GmbHNAC2026-08-26
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00197998152283Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998152313Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998152344Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998152375Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998305801Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
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00197998305863Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998305894Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998305924Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998305955Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998305986Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998415500Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998415548Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
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00197998418976Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998419010Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998419058Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
00197998419829Solventum™ Tegaderm™Solventum Germany GmbHNAC2026-08-23
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06940610127725VliwasorbHuizhou Foryou Medical Devices Co., Ltd.NAC2026-08-14
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06940610127848VliwasorbHuizhou Foryou Medical Devices Co., Ltd.NAC2026-08-14
06940610127879VliwasorbHuizhou Foryou Medical Devices Co., Ltd.NAC2026-08-14