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510(k) Data Aggregation
K Number
K022995Device Name
COLLATEK HYDROGEL
Manufacturer
BIOCORE MEDICAL TECHNOLOGIES, INC.
Date Cleared
2002-12-02
(84 days)
Product Code
MGQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
BIOCORE MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Collatek is indicated for dry, light and moderately exudating partial and full thickness wounds such as:
- First and second degree burns
- Severe sunburns
- Superficial injuries, cuts, abrasions and surgical wounds
Collatek Hydrogel may be used under clinical guidance in the management of the following types of dry, light and moderately exudating partial and full thickness wounds:
- Pressure (stage I-IV) and venous stasis ulcers
- Ulcers caused by mixed vascular etiologies
- Diabetic ulcers
- Donor sites and grafts
Device Description
Collatek Hydrogel is a sterile wound-dressing from polyacrylic acid and collagen. The dressing encourages healing by maintaining a moist environment at the wound site in the case of dry of lightly exudating wounds. The collagen used in the dressing is from animals born, raised and slaughtered in the USA.
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K Number
K012995Device Name
COLLATEK SHEET
Manufacturer
BIOCORE MEDICAL TECHNOLOGIES, INC.
Date Cleared
2001-10-25
(49 days)
Product Code
MGP
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
BIOCORE MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Collatek Sheet may be used in the management of:
- Partial and full thickness wounds
- Pressure (stage 1-1V) and venous ulcers
- Ulcers caused by mixed vascular etiologies
- Venous stasis and diabetic ulcers
- 1st and 2nd degree burns
- Cuts, abrasions and surgical wounds
Device Description
Collatek® Shect is a stcrile, disposable, single use, wound-dressing device for the management of dermal lesions and injuries. Collatek® Sheet is packaged as a sclfadhering island dressing which is able to conform to most wound sites. Collatek® Sheet consist of a hydrocolloid sheet with a clear adherent medical tape backing on one side and a peel-off silica-coated paper on the other. It is to be used manage full and partial thickness wounds with light exudate.
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K Number
K012997Device Name
COLLATEK FOAM
Manufacturer
BIOCORE MEDICAL TECHNOLOGIES, INC.
Date Cleared
2001-10-25
(49 days)
Product Code
MGP
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
BIOCORE MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Collatek Foam may be used in the management of:
- Partial and full thickness wounds
- Pressure (stage I-IV) and venous ulcers
- Ulcers caused by mixed vascular etiologies
- Venous stasis and diabetic ulcers
- 1st and 2nd degree burns
- Cuts, abrasions and surgical wounds
Device Description
Collatekto Fourn is a sterile, disposable, single use, wound-dressing device for the management of dermal lesions and injuries. It is to be used to manage full and partial thickness wounds with moderate to heavy exudate. Collatek® Foam is composed of two scparate layers: a collagen matrix layer and a medical grade foam layer. Collatek Foam's collagen matrix layer is made from insoluble fibrous type I bovinc collagen derived from cowhide. Collatek@ Foam's foam layer is a medical grade polyurothane fourn. Collatek® Foam will be initially available in a 4"x 4" size pad, additional sizes may be introduced at a later time.
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K Number
K012990Device Name
COLLATEK POWDER
Manufacturer
BIOCORE MEDICAL TECHNOLOGIES, INC.
Date Cleared
2001-10-24
(48 days)
Product Code
KGN
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
BIOCORE MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Collatek Powder may be used in the management of:
- Partial and full thickness wounds
- Pressure (stage I-IV) and venous ulcers
- Ulcers caused by mixed vascular etiologies
- Venous stasis and diabetic ulcers
- 1st and 2nd degree burns
- Cuts, abrasions and surgical wounds
Device Description
Collatek® Powder is a sterile, disposable, single use, wound-dressing device for the management of dermal lesions and injuries. It is to be used to fill in full and partial thickness wounds with moderate to heavy exudate. Collatek® Powder is able to conform to any wound site. Collatek® Powder is a hydrophilic, hydrocolloid wound-powder with a collagen base. Collatek® Powder's collagen is an insoluble fibrous type 1 bovine collagen derived from cowhide. Collatek® Powder will be available in a 1 gram size packet, additional sizes may be introduced at a later time.
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