FDA.reportPublic FDA data

Mepilex® Border Lite

Primary DI
07323190127092
Brand
Mepilex® Border Lite
Company
Mölnlycke Health Care AB
Model
281388
Device description
Mepilex Border Lite 4x4in/10x10cm, CVS
Published
2020-07-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00050428280263PackageGS13In Commercial Distribution
07323190105106PackageGS110In Commercial Distribution
07323190127092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00050428280263000504282802630504282802630050428280263
07323190105106073231901051067323190105106
07323190127092073231901270927323190127092

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
Height0Millimeter
Length0Millimeter
Width0Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature035 Degrees Celsius

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06937935316927Sacral Silicone Superabsorbent DressingShanghai Iso Medical Products Co., Ltd.NAC2026-08-03
06979191881955OKTAPEHTT Technologies, Inc.NAC2026-07-31
06979191881962OKTAPEHTT Technologies, Inc.NAC2026-07-31
06979191881979OKTAPEHTT Technologies, Inc.NAC2026-07-31
06979191882280NanacareWAL-MART STORES, INC.NAC2026-07-31
06974692681561GUANGYIJiangsu Guangyi Medical Dressing Co.,LTD.NAC2026-07-22
01714196634404HydraLock SA with BorderSion Brands LLCNAC2026-07-16
01714196635500HydraLock SA with BorderSion Brands LLCNAC2026-07-16
01714196637702HydraLock SA with BorderSion Brands LLCNAC2026-07-16
10197344175963MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-07-13
10197344175970MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-07-13
10197344175987MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-07-13
00850088144314CARBOUNingbo kehu Medical Technology Co.,Ltd.NAC2026-07-08
00197344111513CURADMEDLINE INDUSTRIES, INC.NAC2026-07-03
00197998001727Solventum™ Kerracel™Solventum US LLCNAC2026-06-27
00197998295812Solventum™ Kerracel™Solventum US LLCNAC2026-06-27
00197998295850Solventum™ Kerracel™Solventum US LLCNAC2026-06-27
00197998295898Solventum™ Kerracel™Solventum US LLCNAC2026-06-27
00197998295942Solventum™ Kerracel™Solventum US LLCNAC2026-06-27
00810178889921ViveCareVIVE HEALTH LLCNAC2026-05-29
00810178889938ViveCareVIVE HEALTH LLCNAC2026-05-29
00810178889945ViveCareVIVE HEALTH LLCNAC2026-05-29
00850087488433CeeportCEEPORT INC.NAC2026-05-29
00850087488440CeeportCEEPORT INC.NAC2026-05-29
00850087488518CeeportCEEPORT INC.NAC2026-05-29
09551031940007DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940014DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940021DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940038DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940045DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22