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510(k) Data Aggregation
K Number
K110042Device Name
MANUKATEX
Manufacturer
MANUKA MEDICAL LIMITED
Date Cleared
2011-03-24
(77 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
MANUKA MEDICAL LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MANUKAtex wound dressings are sterile, single-use wound care dressings for use in moist wound management. MANUKAtex wound dressings may be used Over-The-Counter for:
> Minor Abrasions
> Lacerations
> Minor Cuts
> Minor Scalds and Burns
Under the supervision of a healthcare professional, MANUKAtex wound dressings may be used for:
> Leg Ulcers
> Pressure Ulcers
> 1st and 2nd Degree Burns (Superficial and Partial Thickness)
> Diabetic Foot Ulcers
> Surgical Wounds
> Traumatic Wounds
Device Description
MANUKAtex wound dressings are sterile, single-use wound care dressings for use in moist wound management. The primary device is Leptospermum scoparium honey from New Zealand impregnated into acetate gauze. MANUKAtex is coated with carboxymethyl cellulose (CMC). The device incorporates 100% active Leptospermum scoparium medical grade Manuka honey that is harvested and processed under controlled conditions.
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K Number
K102659Device Name
MANUKAHD, MANUKAHD ROPE, MANUKAHD BORDER
Manufacturer
MANUKA MEDICAL LIMITED
Date Cleared
2010-12-08
(84 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
MANUKA MEDICAL LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MANUKAhd wound dressings are highly absorbent, sterile, single-use wound care dressings, with or without adhesive borders, for use in moist wound management. MANUKAhd wound dressings may be used Over-The-Counter for:
- Minor Abrasions
- Lacerations
- Minor Cuts
- Minor Scalds and Burns
Under the supervision of a healthcare professional, MANUKAhd wound dressings may be used for:
- Leg Ulcers
- Pressure Ulcers
- 1st and 2nd Degree Burns (Superficial and Partial Thickness)
- Diabetic Foot Ulcers
- Surgical Wounds
- Traumatic Wounds
Device Description
MANUKAhd wound dressings are highly absorbent, sterile, single-use wound care dressings for use in moist wound management. The primary device is a super absorbent polymer (SAP) fibre material impregnated with medical grade Manuka honey and coated with carboxymethyl cellulose (CMC). The device incorporates 100% active Leptospermum medical grade Manuka honey that is harvested and processed under controlled conditions. One version of the product (MANUKAhd Border) has the honey-impregnated pad retained in a central position on an adhesive backing. Another version of the device (MANUKAhd Rope) is identical to the primary device, but spiral cut to provide the care provider flexibility in packing a wound bed.
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K Number
K092689Device Name
MANUKAPLI WOUND DRESSING
Manufacturer
MANUKA MEDICAL LIMITED
Date Cleared
2010-05-20
(260 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
MANUKA MEDICAL LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Manukapli Wound Dressings are sterile, single-use wound care dressings for use in moist wound management. Manukapli Wound Dressings may be used Over-The-Counter for:
- Minor Abrasions
- Lacerations
- Minor Cuts
- Minor Scalds and Burns
Under the supervision of a healthcare professional, Manukapli Wound Dressings may be used for:
- Leg Ulcers
- Pressure Ulcers
- 1st and 2nd Degree Burns (superficial and Partial Thickness)
- Diabetic Foot Ulcers
- Surgical Wounds
- Traumatic Wounds
Device Description
Manukapli Wound Dressing consists of a sterile wound dressing designed to promote a moist wound healing environment. The device is constructed using medical grade Manukapli that is harvested and processed under controlled conditions. This Manukapli is sealed into polyethylene tubes before sterilization using gamma irradiation and is intended to be used by medical staff as part of a treatment program for patients with problematic wound care requirements. The device is provided sterile and is designed to be single used only. This is achieved by the tube design having a twist & shear off end cap that cannot be replaced.
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