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Found 8 results
510(k) Data Aggregation
K Number
K160695Device Name
Talymed Suspension
Manufacturer
Marine Polymer Technologies, Inc.
Date Cleared
2016-12-06
(267 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Marine Polymer Technologies, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K111524Device Name
MP 719
Manufacturer
MARINE POLYMER TECHNOLOGIES, INC.
Date Cleared
2011-07-22
(50 days)
Product Code
MTJ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
MARINE POLYMER TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MP 719 is indicated for use as an implant material and for use in the control of bleeding from bone surfaces. The material may be used during surgical procedures and in treating traumatic injuries. MP719 is intended for use under the direction of a healthcare professional.
Device Description
MP 719 is a sterile, resorbable, non-woven membrane material comprised of shortened fibers of poly-N-acetyl glucosamine, isolated from microalgae, intended for use in the management of bleeding. MP 719 is available in a range of sizes from 4cm x 4cm to 10cm x 10cm.
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K Number
K082703Device Name
MRDH BANDAGE
Manufacturer
MARINE POLYMER TECHNOLOGIES, INC.
Date Cleared
2008-10-14
(28 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
MARINE POLYMER TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
mRDH Bandage™ is a trauma dressing intended for the temporary control of severely bleeding wounds such as surgical wounds (operative, postoperative, donor sites, dermatological, etc.) and traumatic injuries.
Device Description
mRDH Bandage " is a soft. white, sterile non-woven lyophilized pad of a cellulosic polymer isolated from microalgae (poly-N-acetylglucosamine). It is attached to x-ray detectable gauze and packaged in a sterile blister pack. mRDH Bandage" is available as a 4in x 4in (10cm x 10cm) bandage.
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K Number
K070557Device Name
MP 719
Manufacturer
MARINE POLYMER TECHNOLOGIES, INC.
Date Cleared
2007-05-23
(85 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
MARINE POLYMER TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TALIDERM™ is intended for use under the direction of a healthcare professional.
TALIDERM™ is indicated for the management of wounds including: Diabetic ulcers Venous ulcers Pressure wounds Ulcers caused by mixed vascular etiologies Full thickness and partial thickness wounds Second degree burns Surgical wounds-donor sites/grafts, post-mohr's surgery, and other bleeding surface wounds Abrasions Traumatic wounds healing by secondary intention Dehisced surgical wounds.
Device Description
TALIDERM™ is a sterile primary wound dressing comprised of shortened fibers of poly-N-acetyl glucosamine, isolated from microalgae.
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K Number
K053300Device Name
SYVEKEXCEL
Manufacturer
MARINE POLYMER TECHNOLOGIES, INC.
Date Cleared
2006-03-28
(123 days)
Product Code
DXC
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
MARINE POLYMER TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Syvekexcel® Vascular Access Hemostasis System is intended for use following femoral vascular catheterization procedures to assist in obtaining and maintaining hemostasis.
Device Description
Syvekexed® Vascular Access Hemostasis System consists of four (4) components in a kit:
- 1. a Syvekexcel® Patch 3 cm x 4cm lyophilized pad of poly-N-acetylglucosamine with foam backing,
- a disposable Polypropylene support structure, which snaps on to component 3, 2.
- 3. a reusable Plexiglas handle, and
- 4. a Tegaderm® transparent adhesive bandage
Syvekexcel® Vascular Access Hemostasis System is used to apply direct pressure to obtain and maintain hemostasis, in a similar fashion to direct manual pressure on the access site or at a pressure point. After hemostasis has been achieved the Syvekexcel® Patch is covered with the Tegaderm transparent adhesive bandage.
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K Number
K002550Device Name
RDH BANDAGE
Manufacturer
MARINE POLYMER TECHNOLOGIES, INC.
Date Cleared
2000-12-20
(125 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
MARINE POLYMER TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K984177Device Name
MODIFICATION TO SKVEKPATCH
Manufacturer
MARINE POLYMER TECHNOLOGIES, INC.
Date Cleared
1998-12-18
(28 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
MARINE POLYMER TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ProDein™Patch is indicated for use in the local management of bleeding wounds such as lacerations, abrasions and nose bleeds.
SyvekPatch™ is intended for use under the direction of a healthcare professional for the following indications: SyvekPatch™ is indicated for the promotion of rapid control of bleeding in patients following hemodialysis and in patients on anticoagulation therapy. SyvekPatch™ is indicated for use in the local management of bleeding wounds such as vascular access site, percutaneous catheters or tubes and surgical debridement.
Device Description
Not Found
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K Number
K972914Device Name
SYVEK PATCH
Manufacturer
MARINE POLYMER TECHNOLOGIES, INC.
Date Cleared
1997-12-22
(137 days)
Product Code
KGX
Regulation Number
880.5240Why did this record match?
Applicant Name (Manufacturer) :
MARINE POLYMER TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Syvek Patch ™ is intended for the promotion of rapid control of bleeding in patients following hemodialysis and in patients on anticoagulation therapy.
Device Description
Not Found
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