L-Mesitran Active

GUDID 87172496807278

L-Mesitran Active Dressings are hydro-active hydrogel wound dressings containing honey.

Theo Manufacturing B.V.

Wound hydrogel dressing, antimicrobial

• Primary Device ID: 87172496807278
• NIH Device Record Key: 6773553f-1c85-4b7d-a6be-3de57c087f3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: L-Mesitran Active
• Version Model Number: 511.05
• Company DUNS: 408656143
• Company Name: Theo Manufacturing B.V.
• Device Count: 5
• 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: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	08717249680727 [Primary]
GS1	87172496807278 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053613

FDA Product Code

• FRO: Dressing, Wound, Drug

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: 2023-03-27
• Device Publish Date: 2023-03-17

Devices Manufactured by Theo Manufacturing B.V.

• 08717249680833 - L-Mesitran Tulle: 2023-03-27 L-Mesitran Tulle are wound dressings for the use on wounds. L-Mesitran Tulle is a non-adherent polyethylene dressing impregnated
• 87172496807278 - L-Mesitran Active: 2023-03-27L-Mesitran Active Dressings are hydro-active hydrogel wound dressings containing honey.
• 87172496807278 - L-Mesitran Active: 2023-03-27 L-Mesitran Active Dressings are hydro-active hydrogel wound dressings containing honey.
• 08717249680734 - L-Mesitran Soft 0.5oz: 2023-03-27 L-Mesitran Soft is wound dressing for the use on wounds. L-Mesitran Soft is a gel that contains: 40% medical grade honey, lanoli
• 08717249680741 - L-Mesitran Soft 1.75oz: 2023-03-27 L-Mesitran Soft is wound dressing for the use on wounds. L-Mesitran Soft is a gel that contains: 40% medical grade honey, lanoli
• 08717249680840 - L-Mesitran Hydro: 2023-03-27 L-Mesitran Hydro dressings are hydro-active hydrogel wound dressings containing honey.
• 08717249680857 - L-Mesitran Border: 2023-03-27 L-Mesitran Border dressings are hydro-active hydrogel wound dressings containing honey.