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510(k) Data Aggregation
K Number
K040283Device Name
BIOPAD
Manufacturer
EURORESEARCH S.R.L.
Date Cleared
2005-07-22
(532 days)
Product Code
QSY, FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
EURORESEARCH S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BIOPAD® is a collagen wound dressing intended for the control of minor bleeding, and for the local management of moderately to heavy exuding wounds including:
- pressure ulcers,
- venous stasis ulcers,
- diabetic ulcers,
- partial and full thickness wounds,
- surgical and traumatic wounds,
- surgicul and other bleeding surface wounds
- dehisced surgical incisions
- draining wounds
- lacerations
- podiatric
- post-laser surgery
The product is supplied sterile and for one-time-use only.
Device Description
BIOPAD® is a wound dressing for topical use to control minor bleedings and for the management of any kind of ulcer and skin lesion to help wound closure.
BIOPAD® is a sponge shaped device, constituted exclusively by lyophilized type 1 native heterologous collagen extracted from horse flexor tendon.
When applied to a wound, BIOPAD® constitutes a barrier for wound against exogenous infective agents.
BIOPAD® is the ideal first-aid means to control minor bleeding.
The device may be used by healthcare professionals.
BIOPAD® is supplied sterile and for one-time use only.
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