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510(k) Data Aggregation
K Number
K091636Device Name
OSTENE CT, AOC CT, OSTEOTENE, CERETENE
Manufacturer
CEREMED INC.
Date Cleared
2009-06-22
(18 days)
Product Code
MTJ, PRE
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
CEREMED INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OSTENE®CT is indicated for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
Device Description
Ostene®CT is an odorless, opaque wax-like material designed to be utilized directly out of the package. It is best used immediately following removal from the package, and can be softened and increased in stickiness by warming and by additional handling and manipulation, if so desired.
Ostene®CT is comprised of a sterile mixture of water-soluble alkylene oxide copolymers, derived from ethylene oxide and propylene oxide. * Ostene® CT contains no other additives or colorants. The wax-like material is formed into sticks of various weights ranging from .5 to 5 grams each.
As a bone hemostasis agent, Ostene®CT stops bone bleeding by the creation of a physical barrier along the edges of bones that have been damaged by trauma or cut during a surgical procedure. Ostene CT, when placed on bone under moderate pressure, plugs the vascular openings in the bone. This plug prevents further bleeding.
Ostene®CT is provided sterile by irradiation and must not be resterilized. * A substitution has been made in a neutral excipient copolymer.
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K Number
K070093Device Name
OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTE
Manufacturer
CEREMED INC.
Date Cleared
2007-01-24
(14 days)
Product Code
KHJ, MTJ
Regulation Number
874.3620Why did this record match?
Applicant Name (Manufacturer) :
CEREMED INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OSTENE® is indicated for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
Device Description
Ostene is an odorless, opaque wax-like material designed to be utilized directly out of the package. It is best used immediately following removal from the package, and can be softened and increased in stickiness by warming and by additional handling and manipulation, if so desired.
Ostene is comprised of a sterile mixture of water-soluble alkylene oxide copolymers, derived from ethylene oxide and propylene oxide. Ostene contains no other additives or colorants. The wax-like material is formed into sticks of various weights ranging from .5 to 5 grams each.
As a bone hemostasis agent, Ostene stops bone bleeding by the creation of a physical barrier along the edges of bones that have been damaged by trauma or cut during a surgical procedure. Ostene, when placed on bone under moderate pressure, plugs the vascular openings in the bone. This plug prevents further bleeding.
Ostene is provided sterile by irradiation and must not be resterilized.
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K Number
K041363Device Name
AOC BONE WAX
Manufacturer
CEREMED INC.
Date Cleared
2004-07-27
(67 days)
Product Code
MTJ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
CEREMED INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AOC Bone Wax is intended for use in the control of bleeding from bone surfaces.
Device Description
Desertifican of this an odorless, opaque wax-like material designed to be utilized directly AOC Done Wage. It is best used immediately following removal from the package, and our of the packager over cased in stickiness by additional handling and manipulation, if so can be of ence wax is provided sterile by irradiation and must not be resterilized.
Used for over 100 years, bone waxes stop bone bleeding by the creation of a physical Osed for over he edges of bones that have been damaged by trauma or cut during a surgical procedure. The wax, when placed on bone under moderate pressure, plugs the vascular openings in the bone. This plug prevents further bleeding.
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