Mepitel®

GUDID 07333350575403

Mepitel 10x18cm

Mölnlycke Health Care AB

Wound-nonadherent dressing, permeable, non-antimicrobial

• Primary Device ID: 07333350575403
• NIH Device Record Key: 2fb4faa1-0911-45d9-bbfa-f32acc401b5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mepitel®
• Version Model Number: 291040
• Company DUNS: 631770658
• Company Name: Mölnlycke Health Care AB
• Device Count: 1
• DM Exempt: false
• 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: true
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07333350199036 [Primary]
GS1	07333350575403 [Package]; Contains: 07333350199036; Package: PACK_OR_INNER_PACK [10 Units]; In Commercial Distribution
GS1	07333350611316 [Package]; Package: CASE [7 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161797

FDA Product Code

• OMP: negative pressure wound therapy Powered suction pump

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-16
• Device Publish Date: 2023-03-08

On-Brand Devices [Mepitel®]

• 07332551585303: Mepitel 20x30cm
• 07332551585341: Mepitel 10x18cm, US
• 07332551585150: Mepitel 7,5x10cm, US
• 07332551581268: Mepitel 5x7,5cm, US
• 07333350979195: Mepitel 7,5x10cm
• 07333350287719: Mepitel 5x7,5cm
• 07333350575403: Mepitel 10x18cm
• 07333350579074: Mepitel 20x30cm