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510(k) Data Aggregation
K Number
K143527Device Name
IPM Wound Gel Bio, IPM Derm Gel Bio
Manufacturer
GLYCOBIOSCIENCES, INC
Date Cleared
2015-04-20
(129 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
GLYCOBIOSCIENCES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For Over-the-Counter Use:
IPM Wound Gel Bio/IPM Derm Gel Bio is indicated for management of minor burns (1st degree burns), minor abrasions, minor cuts and helps to relieve dry waxy skin irritations associated with dry skin conditions.
Prescription Use:
Under the supervision of a healthcare professional:
· IPM Wound Gel Bio/IPM Derm Gel Bio is indicated for management of exudating wounds such as leg ulcers, pressure ulcers, diabetic ulcers, surgical wounds (post-operative and donor sites), mechanically debrided wounds, and for second degree burns.
• IPM Wound Gel Bio/IPM Derm Gel Bio is indicated for the management and relief of burning, itching and pain associated with various types of dermatoses; including atopic dermatitis, allergic contact dermatitis.
Device Description
IPM Wound Gel Bio/IPM Derm Gel Bio is a clear viscous, odorless, aqueous gel, composed principally of sodium hyaluronate, a derivative salt of hyaluronic acid. The proportion of sodium hyaluronate "w/w" in the formulation is 2.5%.
Hyaluronic acid is a molecule which is normally found in various parts of the body. Hyaluronic acid in IPM Wound Gel Bio and IPM Derm Gel Bio is derived from a synthetic source, more specifically from a bacterial fermentation process. IPM Wound Gel Bio and IPM Derm Gel Bio serves to maintain a moist environment. The maintenance of moist environment is widely recognized to positively contribute to wound healing process. IPM Wound Gel Bio/ IPM Derm Gel Bio helps to relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
Other ingredients in IPM Wound Gel Bio and IPM Derm Gel Bio are as follows: hydroxyethyl cellulose (1%), methylparaben (0.2%), as well as polyethylene glycol (3%) and purified water, USP (approx. 93%).
IPM Wound Gel Bio and IPM Derm Gel Bio are presented in the following packaging formats: -a carton box with 4 laminated tubes of 10g (0.35oz) -a carton box with one laminated tube of 75g (2.65oz).
IPM Wound Gel Bio and IPM Derm Gel Bio are exactly the same in all aspects and specifications; these are the same device with two (2) different trade names.
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K Number
K123193Device Name
IPM WOUND GEL BIO
Manufacturer
GLYCOBIOSCIENCES, INC
Date Cleared
2014-03-03
(508 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
GLYCOBIOSCIENCES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
"OTC": IPM Wound Gel Bio is indicated for management of minor burns (1st degree burns), minor abrasions, minor cuts and helps to relieve dry waxy skin irritations associated with dry skin conditions.
Rx: Under the supervision of a health care professional; • IPM Wound Gel Bio is indicated for management of exudating wounds such as leg ulcers, pressure ulcers, diabetic ulcers, surgical wounds (postoperative incisions and donor sites), mechanically or surgically debrided wounds, and for second degree burns.
Device Description
IPM Wound Gel Bio is a clear viscous, odorless, aqueous gel, composed principally of sodium hyaluronate, a derivative salt of Hyaluronic acid. The proportion of sodium hyaluronate "w/w" in the formulation is 2.5%. Hyaluronic acid is a molecule which is normally found in various parts of the body. Hyaluronic acid is an extracellular matrix component of human skin. The Hyaluronic acid used in IPM Wound Gel Bio is derived from a synthetic source, more specifically from a bacterial fermentation process. IPM Wound Gel Bio serves to maintain a moist wound environment. The maintenance of a moist wound environment is widely recognized to positively contribute to wound healing process. Other ingredients in IPM Wound Gel Bio are as follows: hydroxyethyl cellulose (1%), methylparaben (0.2%), as well as polyethylene glycol (3%) and purified water, USP (approx. 93%). IPM Wound Gel Bio is presented in carton boxes with 4 laminated tubes of 10g (0.35oz).
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K Number
K130781Device Name
L.A.M. IPM WOUND GEL, IPM DERM GEL
Manufacturer
GLYCOBIOSCIENCES, INC
Date Cleared
2014-02-14
(330 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
GLYCOBIOSCIENCES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
"OTC":
L.A.M. IPM Wound Gel/IPM Derm Gel is indicated for management of minor burns (1ª degree burns), minor abrasions, minor cuts and helps to relieve dry waxy skin irritations associated with dry skin conditions.
Rx:
Under the supervision of a health care professional;
· L.A.M. IPM Wound Gel/IPM Derm Gel is indicated for management of exudating wounds such as leg ulcers, pressure ulcers, diabetic ulcers, surgical wounds (post-operative incisions and donor sites), mechanically or surgically debrided wounds, and for second degree burns.
· L.A.M. IPM Wound Gel/IPM Derm Gel is indicated for the management and relief of burning, itching and pain associated with various types of dermatoses; including atopic dermatitis, allergic contact dermatitis and radio-dermatitis.
Device Description
L.A.M. IPM Wound Gel/IPM Derm Gel is a clear viscous, odourless, aqueous gel, composed principally of sodium hyaluronate, a derivative salt of Hyaluronic acid. The proportion of sodium hyaluronate "w/w" in the formulation is 2.5%.
Hyaluronic acid is a molecule which is normally found in various parts of the body. Hyaluronic acid in L.A.M. IPM Wound Gel and IPM Derm Gel is derived from avian sources. L.A.M. IPM Wound Gel and IPM Derm Gel serves to maintain a moist wound environment. The maintenance of a moist wound environment is widely recognized to positively contribute to wound healing process. L.A.M. IPM Wound Gel/ IPM Derm Gel helps to relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
Other ingredients in L.A.M. IPM Wound Gel and IPM Derm Gel are as follows: hydroxyethyl cellulose (1%), methylparaben (0.2%), as well as polyethylene glycol (3%) and purified water, USP (approx. 93%).
L.A.M. IPM Wound Gel and IPM Derm Gel are presented in carton boxes with 4 laminated tubes of 10g (0.35oz).
L.A.M. IPM Wound Gel and IPM Derm Gel are exactly the same in every aspect and specifications; they are the same device with two (2) different trade names.
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K Number
K123113Device Name
L.A.M. IMP WOUND GEL
Manufacturer
GLYCOBIOSCIENCES, INC
Date Cleared
2012-12-11
(69 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
GLYCOBIOSCIENCES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OTC: L.A.M. IPM Wound Gel is indicated for the manugement of minor burns (16 degree burns), minor abrasions and minor cuts. Rx: Under the supervision of a healthcare professional L.A.M. IPM Wound Gel is indicated for the management of exudating wounds such as leg ulcers, pressure ulcers, diabetic ulcers, surgical wounds (post-operative incisions and donor sites), mechanically or surgically debrided wounds, and 2nd degree burns
Device Description
L.A.M. IPM Wound Gel is a clear viscous, odoricss, aqueous gel composed principally of sodium hyaluronate, a derivative salt of Hyaluronic acid. L.A.M. IPM Wound Gel provides a moist wound environment that is supportive to wound healing. Over-thecounter use of L.A.M. IPM Wound Gel is suitable for minor burns, minor abrasions, and minor cuts. Under the supervision of a healthcare professional, L.A.M. IPM Wound Gel is suitable for exudating wounds such as leg ulcers, pressure ulcers, diabetic ulcers, surgical wounds (post-operative incisions and donor sites), for the management of mechanically or surgically debrided wounds, and for second degree burns.
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