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510(k) Data Aggregation
K Number
K162017Device Name
Ross Ru Wound Dressing Gel
Manufacturer
BIOTD, S.A.
Date Cleared
2017-04-20
(273 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
BIOTD, S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ross Ru Wound Dressing Gel is indicated for use in the management of 1st and 2nd degree burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, skin tears, surgical incision sites, device insertion site wounds, graft sites and donor sites.
Device Description
Ross Ru is a wound dressing gel that helps maintain a moist wound environment that is conducive to healing, by either absorbing or donating the moisture and wound exudates. Ross Ru Wound Dressing Gel is supplied in a collapsible low density polyethylene tube sealed at one end and fitted with a dispensing orifice at the other end accessible by the removal of its screw cap.
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K Number
K141637Device Name
SPB SKIN EMULSION
Manufacturer
BIOTD, S.A.
Date Cleared
2015-06-03
(349 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
BIOTD, S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Prescription Use: As a prescription topical skin care emulsion to manage and relieve the burning and itching experienced with various types of dermatoses, including atopic and allerge contact dermatitis. SPB helps maintain a moist wound & skin environment, which is be healing process.
Over-The-Counter Use: An OTC topical skin care emulsion to relieve the burning associated with many common types of skin irritation. SP helps maintain a moist wound & skin environment, which is beneficial to the healing process.
Device Description
SPB Skin Emulsion is a topical skin care emulsion that is indicated to manage and relieve the burning and itching experienced with various types of dermatoses, including atopic and allergic contact dermatitis. SPB Skin Emulsion contains natural extracts to moisturize the skin.
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K Number
K131176Device Name
ROSS RU SKIN DISCONTINUITIES
Manufacturer
BIOTD, S.A.
Date Cleared
2014-05-12
(382 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
BIOTD, S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
An over-the-counter (OTC) product for topical management of minor cuts, lacerations, abrasions, 1st and 2nd degree burns, and skin irritations.
Device Description
Ross Ru is a wound dressing gel that helps maintain a moist wound environment that is conducive to healing, by either absorbing or donating the moisture and wound exudates and may inhibit the growth of microorganisms within the dressing. Ross Ru Skin Discontinuities is supplied in a collapsible low density polyethylene tube sealed at one end and fitted with a dispensing orifice at the other end accessible by the removal of its screw cap.
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