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Found 8 results
510(k) Data Aggregation
K Number
K133290Device Name
COLLACARE DENTAL
Manufacturer
INNOCOLL PHARMACEUTICALS
Date Cleared
2014-05-01
(188 days)
Product Code
KGN, CLA
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
INNOCOLL PHARMACEUTICALS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Collacare Dental is indicated for the management of oral wounds and sores, including:
- denture sores
- oral ulcers (non-infected or viral)
- periodontal surgical wounds
- suture sites
- burns
- surgical wounds and traumatic wounds
Device Description
Collacare Dental is a collagen matrix, conformable and resorbable, manufactured from purified type I collagen derived from bovine Achilles tendon. Collacare Dental is supplied sterile and non-pyrogenic, in various sizes, and for single use only. Sizes available include the following:
Dental Sponges: 3.6cm x 1.8cm, 2.5cm x 2.5cm and 2.5cm x 5cm
Dental Cone: Height-17mm Ø Top - 10mm Ø Bottom - 14mm
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K Number
K120339Device Name
PROCOLL
Manufacturer
INNOCOLL PHARMACEUTICALS
Date Cleared
2012-06-21
(139 days)
Product Code
KGN, CLA
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
INNOCOLL PHARMACEUTICALS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Procoll may be used for the management of full and partial thickness wounds including:
- Diabetic ulcers .
- . Venous ulcers
- Pressure ulcers .
- Ulcers caused by mixed vascular etiologies
- Abrasions .
- . Traumatic wounds
- 1st and 2nd degree burns .
- Dehisced surgical wounds .
- Exuding wounds .
Device Description
Procoll is a collagen matrix, conformable and resorbable, manufactured from purified type I collagen derived from bovine Achilles tendon. Procoll is supplied sterile and non-pyrogenic, in various sizes, and for single use only.
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K Number
K103648Device Name
COLLAGEN POWDER
Manufacturer
INNOCOLL PHARMACEUTICALS LTD
Date Cleared
2011-09-14
(274 days)
Product Code
KGN, CLA
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
INNOCOLL PHARMACEUTICALS LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Collagen Powder may be used for the management of wounds such as:
- Diabetic ulcers
- Venous ulcers
- Pressure ulcers
- Ulcers caused by mixed vascular etiologies
- Full-thickness & partial thickness wounds
- Abrasions
- Traumatic wounds
- 1st and 2nd degree burns
- Dehisced surgical wounds
- Exuding wounds
Device Description
Collagen Powder is a collagen matrix in powder form intended for application as a wound management device. The product is supplied sterile for single use only.
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K Number
K110388Device Name
COLLACARE DENTAL
Manufacturer
INNOCOLL PHARMACEUTICALS LTD
Date Cleared
2011-08-09
(180 days)
Product Code
KGN, CLA
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
INNOCOLL PHARMACEUTICALS LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Collacare Dental is indicated for the management of oral wounds and sores, including:
- denture sores
- oral ulcers (non-infected or viral)
- periodontal surgical wounds
- suture sites
- burns
- surgical wounds and traumatic wounds
Device Description
Collacare Dental is a conformable collagen matrix manufactured from purified type I collagen derived from bovine Achilles tendon. Collacare Dental is supplied sterile and non-pyrogenic, in various sizes, and for single use only.
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K Number
K100574Device Name
COLLEXA
Manufacturer
INNOCOLL PHARMACEUTICALS
Date Cleared
2010-10-28
(241 days)
Product Code
KGN
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
INNOCOLL PHARMACEUTICALS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Collexa may be used for the management of wounds such as:
- Diabetic ulcers
- · Venous ulcers
- . Pressure ulcers
- Ulcers caused by mixed vascular etiologies .
- Full-thickness & partial thickness wounds .
- Abrasions .
- Traumatic wounds .
- 1st and 2nd degree burns .
- Dehisced surgical wounds .
- Exuding wounds .
Device Description
Collexa is a collagen matrix sponge with a polyurethane foam backing intended for topical use on wounds as described in the intended use section of this 510(k) summary. The polyurethane foam is absorbent and acts as a reservoir for wound exudates. The product is supplied sterile for single use only.
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K Number
K092805Device Name
COLLAGEN SPONGE
Manufacturer
INNOCOLL PHARMACEUTICALS
Date Cleared
2010-02-16
(158 days)
Product Code
KGN
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
INNOCOLL PHARMACEUTICALS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Collagen Sponge may be used for the management of wounds such as:
- Pressure ulcers .
- . Venous stasis ulcers
- . Diabetic ulcers
- First and second degree burns .
- Partial and full thickness wounds .
- Superficial injuries .
Device Description
Collagen Sponge is a collagen matrix sponge intended for topical use. The product is supplied sterile for single use only.
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K Number
K081782Device Name
COLLIEVA
Manufacturer
INNOCOLL PHARMACEUTICALS
Date Cleared
2008-09-30
(99 days)
Product Code
KGN
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
INNOCOLL PHARMACEUTICALS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Collieva™ may be used for the management of wounds such as:
- · Pressure ulcers
- Venous stasis ulcers
- · Diabetic ulcers
- · First and second degree burns
- · Partial and full thickness wounds
- · Superficial injuries
Device Description
Collieva™ is a clear collagen matrix film intended for topical use. The product is supplied sterile for single use only.
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K Number
K061746Device Name
COLLAGUARD, MODEL FCIA,FCIB,FCIC,AND FCID
Manufacturer
INNOCOLL PHARMACEUTICALS
Date Cleared
2006-10-02
(103 days)
Product Code
KGN, KMF
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
INNOCOLL PHARMACEUTICALS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CollaGUARD may be used for the management of wounds such as:
- Pressure ulcers .
- . Venous stasis ulcers
- . Diabetic ulcers
- First and second degree burns .
- Partial and full thickness wounds .
- Superficial injuries .
Device Description
CollaGUARD™ is a clear collagen matrix film intended for topical use. The product is supplied sterile for single use only.
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