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510(k) Data Aggregation
K Number
K173005Device Name
SURECELL Gelling Fiber Wound Dressing
Manufacturer
Date Cleared
2018-05-25
(240 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Jiangsu Newvalue Medical Producst Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Rx Indication: Under professional medical care, SURECELL Gelling Fiber Wound Dressing may be used for the management of: Leg ulcers (Stage I-IV), Diabetic ulcers, Surgical wounds (e.g. post-operative, donor sites, dermatological), Pressure ulcers, Burns (1st and 2nd degree), and Surgical or traumatic wounds which have been left to heal by secondary intention. SURECELL Gelling Fiber Wound Dressing maintains a moist wound environment. SURECELL Gelling Fiber Wound Dressing may also be used for the local management of wounds such as wounds that have been surgically or mechanically debrided, donor sites, and traumatic wounds.
OTC Indication: SURECELL Gelling Fiber Wound Dressing Over-the-Counter is indicated for minor Burns, minor abrasions and minor Lacerations, minor superficial cuts. SURECELL Gelling Fiber Wound Dressing is intended for the maintenance of a moist wound environment.
Device Description
SURECELL™ Gelling Fiber Wound Dressing is a sterile non-woven wound dressing composed of hydrophilic fiber (a mixture of chitosan and chitosan derivatives). This soft and highly absorbent dressing vertically absorbs wound exudate and creates a comfortable clear gel to maintain a moist environment for optimal wound healing.
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