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510(k) Data Aggregation
K Number
K242634Device Name
PuraStat
Manufacturer
3-D Matrix Europe SAS
Date Cleared
2025-01-15
(134 days)
Product Code
PHN
Regulation Number
N/AWhy did this record match?
Product Code :
PHN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Purastat is indicated for the symptomatic management of rectal mucositis, such as radiation proctitis that may be caused by chemotherapy or radiotherapy.
Device Description
PuraStat is a sterile gel composed of a synthetic peptide and sterile water for injection. It is provided as a prefilled syringe (2.5% peptide content) ready for use as a mucoadhesive hydrogel that provides a protective barrier over rectal mucosa. The gel is delivered to the intended application site(s) via a commercially available endoscopic catheter that is attached to the gel-filled syringe via the polypropylene adapter (Class 1 - 510k Exempt) also commercially available (Class 1. 510k Exempt).
PuraStat is completely non-animal and non-plant derived and contains no preservatives that might present a risk of allergic reaction or skin irritation.
Exposure to physiological fluids such as blood causes the peptide solution to quickly form a transparent gel without expansion in volume.
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K Number
K213552Device Name
PuraStat-RM
Manufacturer
3-D Matrix, Inc.
Date Cleared
2022-04-01
(144 days)
Product Code
PHN
Regulation Number
N/AWhy did this record match?
Product Code :
PHN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PuraStat-RM is indicated for the symptomatic management of rectal mucositis, such as radiation proctitis that may be caused by chemotherapy or radiotherapy.
Device Description
PuraStat-RM is a sterile gel composed of a synthetic peptide and sterile water for injection. It is provided as a prefilled syringe (2.5% peptide content) ready for use as a mucoadhesive hydrogel that provides a protective barrier over rectal mucosa. The gel is delivered to the intended application site(s) via a commercially available endoscopic catheter that is attached to the gel syringe via the polypropylene adapter.
PuraStat-RM is completely non-animal and non-plant derived and contains no drugs or biologics that might present a risk of allergic reaction or skin irritation.
Exposure to physiological fluids such as blood causes the peptide solution to quickly form a transparent gel without expansion in volume.
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K Number
K140558Device Name
PROCTIGARD
Manufacturer
ACCESS PHARMACEUTICALS, INC
Date Cleared
2014-07-16
(133 days)
Product Code
PHN
Regulation Number
N/AWhy did this record match?
Product Code :
PHN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ProctiGard™ is indicated for the symptomatic management of rectal mucositis.
Device Description
ProctiGard™ is a viscous, mucoadhesive liquid supplied in plastic bottles and is designed for the symptomatic management of rectal mucositis. When gently applied via the enema bottle applicator, the mucoadhesive formulation results in the formation of a protective coating over the rectal mucosa.
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