Mepore® Film

GUDID 07332551950200

Normlgel Ag 45g

Mölnlycke Health Care AB

Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial

• Primary Device ID: 07332551950200
• NIH Device Record Key: 21f174a1-37b2-43b3-8688-00f154323a90
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mepore® Film
• Version Model Number: 350450
• Company DUNS: 631770658
• Company Name: Mölnlycke Health Care AB
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	07332551950194 [Package]; Package: CASE [3 Units]; In Commercial Distribution
GS1	07332551950200 [Package]; Contains: 07332551958503; Package: PACK_OR_INNER_PACK [10 Units]; In Commercial Distribution
GS1	07332551958503 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110458

FDA Product Code

• FRO: Dressing, wound, drug

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-31
• Device Publish Date: 2022-10-21

On-Brand Devices [Mepore® Film]

• 07332551950200: Normlgel Ag 45g
• 07323190291823: Mepore Film 15x20 cm
• 07323190291892: Mepore Film 10x25 cm
• 07323190291960: Mepore Film 10x12 cm
• 07323190292042: Mepore Film 6x7 cm
• 07323190295104: Unit pack Mepore Film 15x20 cm
• 07323190295043: Unit pack Mepore Film 10x25 cm
• 07323190294992: Unit pack Mepore Film 10x12 cm
• 07323190294831: Unit pack Mepore Film 6x7cm
• 07333350722098: Unit pack Mepore Film 20x30 cm