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510(k) Data Aggregation
K Number
K150676Device Name
L-Mesitran Dressing Family II- Soft and Tulle
Manufacturer
Theo Manufacturing BV
Date Cleared
2015-12-23
(282 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Theo Manufacturing BV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
a) Over-The-Counter (OTC) use
The L-Mesitran Dressing Family II - Soft and Tulle provide a moist environment conducive to wound healing and are indicated for light to moderately exuding wounds. For over the counter use, L-Mesitran Dressing Family II may be used for:
- minor abrasions
- lacerations
- minor cuts
- minor scalds and burns
b) Prescription (Rx) use
Under the supervision of a healthcare professional, The L-Mesitran Dressing Family II - Soft and Tulle provide a moist environment conducive to wound healing and are indicated for light to moderately exuding wounds. The L-Mesitran Dressing Family II is intended for the management of the following:
- Diabetic foot ulcers
- Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology)
- Pressure ulcers / sores (partial and full thickness)
- 1st and 2nd degree partial thickness burns
- Donor sites, and traumatic and surgical wounds
L-Mesitran Soft and Tulle are to be used in conjunction with other secondary dressings.
Device Description
L-Mesitran® Soft and Tulle are wound dressings for the use on wounds
• L-Mesitran® Soft is a gel that contains: 40% medical grade honey, medical grade hypoallergenic lanolin, propylene glycol, PEG 4000, and vitamins C and E.
• L-Mesitran® Tulle is a non-adherent polyethylene dressing impregnated with the patented L-Mesitran® Soft gel.
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K Number
K053613Device Name
L-MESITRAN HYDRO, L-MESITRAN BORDER, L-MESITRAN NET, L-MESITRAN ACTIVE
Manufacturer
THEO MANUFACTURING BV
Date Cleared
2007-07-25
(575 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
THEO MANUFACTURING BV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
L-Mesitran Hydro and Border dressings are indicated for acute and chronic superficial wounds such as: bruises, cuts, bedsores, first and second-degree burns and other traumatic wounds, venous and arterial ulcera, diabetes ulcers, donor sites, and post-operative wounds. L-Mesitran Hydro and Border should not be used as a covering for deep narrow cavities, dirty wounds (these should first be cleansed), third-degree burns and fistulae. Maintains a moist wound healing environment. This moist environment supports optimal wound healing.
L-Mesitran Active dressings are indicated for treating minor burns, superficial cuts, lacerations and abrasions, and other small wounds. Maintains a moist wound healing environment. This moist environment supports optimal wound healing.
L-Mesitran dressings are indicated for acute and chronic superficial wounds such as: bruises, tears, pressure ulcers, venous and arterial ulcera, diabetes ulcers, donor sites, cuts, first and second degree burns, postoperative wounds and other external wounds caused by trauma. L-Mesitran Net is to be used in conjunction with other secondary dressings. It should not be used on its own as a covering for dirty infected and heavily exudating wounds (should first be cleansed), third degree burns, or deep narrow cavities. Maintains a moist wound healing environment. This moist environment supports optimal wound healing.
Device Description
L-Mesitran Hydro, L-Mesitran Border, and L-Mesitran Active are hydro-active hydrogel wound dressings containing honey. L-Mesitran Net is a hydro-active hydrogel coated wound dressing containing honey on an open weave polyester net.
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