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510(k) Data Aggregation
K Number
K183622Device Name
NasalCEASE and BleedCEASE
Manufacturer
Date Cleared
2019-12-02
(341 days)
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Les Laboratoires Brothier S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
OTC: For the local management of bleeding wounds such as minor lacerations, minor abrasions, and minor nosebleeds.
Prescription: For nasal epistaxis and the local management of topical wounds, including both non-infected:
- · Small bleeding surface wounds
- · Small post-surgical incisions
- Abrasions and lacerations
Device Description
BleedCEASE® and NasalCEASE® are the same product with the same indications for use but branded under two different names. The remainder of this summary will refer to the product as BleedCEASE.
BleedCEASE® is made of calcium alginate, an all-natural biopolymer originating from seaweed. When in contact with the wound, BleedCEASE® absorbs blood and releases calcium, becoming a soft gel that conforms to the wound. BleedCEASE stops bleeding without sticking to the wound, reducing the likelihood of pain or rebleeds that may be associated with wound dressing removal.
BleedCEASE® is provided as a sterile, non-woven packing (2cm x 4cm), each packaged in an individual pouch. The product is sold in boxes of 5, 25 and 100 pouches.
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