Mepilex® Border

Primary DI
07323190046416
Brand
Mepilex® Border
Company
Mölnlycke Health Care AB
Model
295300
Device description
Mepilex Border 10x10 cm
Published
2021-03-01
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

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
07323190046409PackageGS110Not in Commercial Distribution
07323190046416PackageGS15Not in Commercial Distribution
07323190047703PackageGS110Not in Commercial Distribution
07323190047710PackageGS15Not in Commercial Distribution
07332430497598PackageGS110Not in Commercial Distribution
07332430497772PackageGS15Not in Commercial Distribution
07310791241173PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07323190046409073231900464097323190046409
07323190046416073231900464167323190046416
07323190047703073231900477037323190047703
07323190047710073231900477107323190047710
07332430497598073324304975987332430497598
07332430497772073324304977727332430497772
07310791241173073107912411737310791241173

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
Length135Millimeter
Width153Millimeter

Storage And Handling#

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

Sterilization Methods#

Method table
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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