FDA.reportPublic FDA data

Mepilex® XT

Primary DI
07323190122974
Brand
Mepilex® XT
Company
Mölnlycke Health Care AB
Model
211015
Device description
Mepilex XT 5x5 cm
Published
2022-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
07323190122974PackageGS18In Commercial Distribution
07323190122981PackageGS15In Commercial Distribution
07323190123889PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07323190122974073231901229747323190122974
07323190122981073231901229817323190122981
07323190123889073231901238897323190123889

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
631770658
Device count
1
DM exempt
true
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07333350181475Mölnlycke®Z-Flo™ Fluidized Positioner14005002026-09-22
07333350455873Mölnlycke®Z-Flo™ Fluidized Positioner14005222026-09-22
07333350647292Mölnlycke®Z-Flo™ Fluidized Positioner14005132026-09-22
07333350743918Mölnlycke®Z-Flo™ Fluidized Positioner14005272026-09-22
07333350775360Mölnlycke®Z-Flo™ Fluidized Positioner14005242026-09-22
07333350030384Tubigrip®14422026-09-21
07333350102111Tubigrip®14392026-09-21
07333350341596Mepitel®2907992026-09-21
07333350354831Tubigrip®14522026-09-21
07333350462161Mölnlycke®Z-Flo™ Fluidized Positioner14011082026-09-21
07333350472917Tubigrip®14502026-09-21
07333350529079Mölnlycke®Z-Flo™ Fluidized Positioner14011052026-09-21
07333350589110Tubigrip®14342026-09-21
07333350644635Tubigrip®14372026-09-21
07333350721589Tubigrip®14352026-09-21
07333350753856Tubigrip®14482026-09-21
07333350758288Tubigrip®14382026-09-21
07333350768249Mölnlycke®Z-Flo™ Fluidized Positioner14011112026-09-21
07333350929640Tubigrip®14492026-09-21
07333350094850Tubigrip®14512026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260223630224curea P1curea medical GmbHNAC2026-09-27
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04260223630255curea P1curea medical GmbHNAC2026-09-27
04260223630262curea P1curea medical GmbHNAC2026-09-27
04260223630279curea P1curea medical GmbHNAC2026-09-27
04260223630286curea P1 draincurea medical GmbHNAC2026-09-27
04260223630347curea P2curea medical GmbHNAC2026-09-27
04260223630378curea P2curea medical GmbHNAC2026-09-27
04260223630408curea P2curea medical GmbHNAC2026-09-27
04260223630422curea P2curea medical GmbHNAC2026-09-27
04260223630651curea P1curea medical GmbHNAC2026-09-27
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04260223630736curea P1curea medical GmbHNAC2026-09-27
04260223630880curea P1curea medical GmbHNAC2026-09-27
04260223630989curea P1 heelcurea medical GmbHNAC2026-09-27
04260223631184curea P1 DUO activecurea medical GmbHNAC2026-09-27
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04260223631368curea P1curea medical GmbHNAC2026-09-27
04260223631672curea P2curea medical GmbHNAC2026-09-27
04260223631696curea P2curea medical GmbHNAC2026-09-27
04260223631757curea P1 DUO activecurea medical GmbHNAC2026-09-27
04260223631771curea P2 activecurea medical GmbHNAC2026-09-27
04260223631795curea P2 activecurea medical GmbHNAC2026-09-27
04260223631849curea P2 activecurea medical GmbHNAC2026-09-27
04260223631931curea P1 easy bordercurea medical GmbHNAC2026-09-27
00749756401920DeRoyalDEROYAL INDUSTRIES, INC.NAC2026-09-18
00841277111286Novera SeamHarps USA, Inc.NAC2026-09-04