FDA.report

Mepilex® Border Lite

Primary DI
00050428280263
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
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
NACDressing, wound, hydrophilic

Product Code Classifications

CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00050428280263PackageGS13Not in Commercial Distribution
07323190105106PackageGS110Not in Commercial Distribution
07323190127092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00050428280263000504282802630504282802630050428280263
07323190105106073231901051067323190105106
07323190127092073231901270927323190127092

GMDN Terms

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

TypeValueUnit
Height0Millimeter
Length0Millimeter
Width0Millimeter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature035 Degrees Celsius

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

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